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Cardiac Safety

Advanced Waveform Analysis of ECG Signals to Characterize Cardiac Drug Safety Between Caucasian & Japanese Volunteers - Poster 077

Advanced Waveform Analysis of ECG Signals to Characterize Cardiac Drug Safety Between Caucasian & Japanese Volunteers - Poster 077

December 10, 2024

Safety assessment during clinical development of candidate drugs involves evaluation of their proarrhythmic propensity through detailed ECG studies...

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Advanced waveform analysis of the electrocardiogram signals using complementary signal processing techniques to investigate the response to a QTc prolonging drug vs control

Advanced waveform analysis of the electrocardiogram signals using complementary signal processing techniques to investigate the response to a QTc prolonging drug vs control

November 12, 2024

Thorough QTc (TQT) studies using Electrocardiogram (ECG) data, are a well-established method for testing the pro-arrhythmic propensity of drugs performed during safety studies as part of drug development...

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Effect of Acoramidis on Myocardial Structure and Function in Transthyretin Amyloid Cardiomyopathy: Insights From the ATTRibute-CM Cardiac Magnetic Resonance(CMR) Substudy

Effect of Acoramidis on Myocardial Structure and Function in Transthyretin Amyloid Cardiomyopathy: Insights From the ATTRibute-CM Cardiac Magnetic Resonance(CMR) Substudy

November 12, 2024

Transthyretin amyloid cardiomyopathy (ATTR-CM) is an increasingly recognized cause of heart failure...

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Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy

Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy

September 13, 2024

Transthyretin amyloidosis with cardiomyopathy (ATTR-CM) is a progressive, fatal disease. Vutrisiran, a subcutaneously...

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Confirmation of the cardiac safety of nolasiban in a randomised cohort of healthy female volunteers

Confirmation of the cardiac safety of nolasiban in a randomised cohort of healthy female volunteers

July 9, 2024

Infertility impacts approximately 15% of couples worldwide causing social, economic...

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Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study

Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study

July 9, 2024

Cardiac microRNA-132-3p (miR-132) levels are increased in patients with heart failure (HF) and mechanistically...

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Haemodynamic effects of the nitroxyl donor cimlanod (BMS-986231) in chronic heart failure: a randomized trial

Haemodynamic effects of the nitroxyl donor cimlanod (BMS-986231) in chronic heart failure: a randomized trial

July 9, 2024

Nitroxyl provokes vasodilatation and inotropic and lusitropic effects in animals via post-translational modification of thiols.

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Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12-lead Holter

Comparing the consistency of electrocardiogram interval measurements by resting ECG versus 12-lead Holter

July 9, 2024

In clinical trials, traditionally only a limited number of 12-lead resting electrocardiograms (ECGs) can be recorded...

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CRISPR-Cas9 in-vivo gene editing shows reduction in TTR after a single dose

CRISPR-Cas9 in-vivo gene editing shows reduction in TTR after a single dose

June 29, 2021

Data produced through and Intellia Therapeutic’s NTLA-2001 FIH clinical trial, conducted at Richmond Pharmacology, indicates a reduction in the faulty TTR protein after a single infusion. Results were presented by Professor Julian Gillmore at this year’s Peripheral Nerve Society Annual Meeting

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Meta-analysis of the effect of a meal on QTcF

Meta-analysis of the effect of a meal on QTcF

December 9, 2020

In this meta-analysis, 12 separate thorough QT studies conducted at Richmond Pharmacology Ltd, London, UK were analysed alongside one another to observe the consistency of the effect of a meal on the QTc interval, and to observe any trends associated with sex.

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Effects of progesterone and estradiol on QT subintervals over the course of a menstrual cycle

Effects of progesterone and estradiol on QT subintervals over the course of a menstrual cycle

September 22, 2020

This study aimed to assess whether there is a reliable evidence for the influence of a menstrual cycle on the duration of cardiac subintervals.

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Do hERG blocking agents further increase the risk of sudden cardiac death in patients with type 1 diabetes?

Do hERG blocking agents further increase the risk of sudden cardiac death in patients with type 1 diabetes?

September 22, 2020

The data from this study suggest that QT prolonging drugs should be administered with caution to type 1 diabetic patients.

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Assay Sensitivity in QT Assessment

Assay Sensitivity in QT Assessment

February 20, 2020

Assay Sensitivity in QT Assessment. Taubel J et al. Journal for Clinical Studies 2015, 7(6): 60-62

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Single Doses up to 800 mg of E-52862

Single Doses up to 800 mg of E-52862

February 20, 2020

Single Doses up to 800 mg of E-52862 Do Not Prolong the QTc Interval – A Retrospective Validation by Pharmacokinetic- Pharmacodynamic Modelling of Electrocardiography Data Utilising the Effects of a Meal on QTc to Demonstrate ECG Assay

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Concentration-Effect Modeling Based on Change From Baseline

Concentration-Effect Modeling Based on Change From Baseline

February 20, 2020

Concentration-Effect Modeling Based on Change From Baseline to Assess the Prolonging Effect of Drugs on QTc Together With an Estimate of the Circadian Time Course. Ferber et al. J Clin Pharmacol, 2014. Submitted for publication 3 April 2014;

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Analyzing the Relationship of QT Interval and Exposure to Nitazoxanide

Analyzing the Relationship of QT Interval and Exposure to Nitazoxanide

February 20, 2020

Analyzing the Relationship of QT Interval and Exposure to Nitazoxanide, a Prospective Candidate for Influenza Antiviral Therapy – A Formal TQT Study. Taubel et al. J Clin Pharmacol, 2014. Submitted for publication 24 February 2014;

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Comparison of the effects of levofloxacin on QT/QTc interval

Comparison of the effects of levofloxacin on QT/QTc interval

February 20, 2020

Comparison of the effects of levofloxacin on QT/QTc interval assessed in both healthy Japanese and Caucasian subjects. Sugiyama et al. Br J Clin Pharmacol 2011;73(3): 455-459

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Bupivacaine Extended Release Liposome Injection

Bupivacaine Extended Release Liposome Injection

February 20, 2020

Bupivacaine Extended Release Liposome Injection Does Not Prolong QTc Interval in a Thorough QT/QTc Study in Healthy Volunteers. Naseem et al. J Clin Pharmacol, 2012;52:1441-1447

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Levofloxacin can be used as a positive control in QT/QTc

Levofloxacin can be used as a positive control in QT/QTc

February 20, 2020

Levofloxacin can be used as a positive control in QT/QTc studies in healthy subjects (paper). Taubel J et al. Br J Clin Pharmacol 2010;69(4):391-400

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Shortening of the QT Interval After Food

Shortening of the QT Interval After Food

February 20, 2020

Shortening of the QT Interval After Food Can Be Used to Demonstrate Assay Sensitivity in Thorough QT Studies. Taubel et al. J Clin Pharmacol, 2012;52:1558-1565

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Comparison of Six Commonly Used QT Correction Models and Their Parameter Estimation Methods

Comparison of Six Commonly Used QT Correction Models and Their Parameter Estimation Methods

February 20, 2020

Comparison of Six Commonly Used QT Correction Models and Their Parameter Estimation Methods. Wang et al. Journal of Biopharmaceutical Statistics 2012; 22(6):1148-1161

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Investigating the Ethnic Differences between the Effect of Moxifloxacin on Cardiac Conduction

Investigating the Ethnic Differences between the Effect of Moxifloxacin on Cardiac Conduction

February 20, 2020

Investigating the Ethnic Differences between the Effect of Moxifloxacin on Cardiac Conduction in Japanese and Caucasians. Dr Jorg Taubel MD FFPM. 5th DIA Cardiac Safety Workshop in Japan, 24 October 2014, Tokyo, Japan

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Mason-Likar electrode configuration

Mason-Likar electrode configuration

February 20, 2020

Mason-Likar electrode configuration can confound the recognition of electrode cable interchange. Velislav N et al. J Electrocard, 2010.12.164

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Thorough QT study of the effect of oral moxifloxacin on QTc interval

Thorough QT study of the effect of oral moxifloxacin on QTc interval

February 20, 2020

Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects. Taubel J et al. Br J Clin Pharmacol 2014;77 (1), 170-179

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Lamotrigine does not prolong QTc in TQT studies

Lamotrigine does not prolong QTc in TQT studies

February 20, 2020

Lamotrigine does not prolong QTc in TQT studies in healthy subjects. Dixon R et al. Br J Clin Pharmacol 2008;66(3):396-404

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Insulin at normal physiological levels does not prolong QTc interval

Insulin at normal physiological levels does not prolong QTc interval

February 20, 2020

Insulin at normal physiological levels does not prolong QTc interval in thorough QT studies performed in healthy volunteers. Taubel et al. Br J Clin Pharmacol 2012;75(2): 392-403

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Repeated supratherapeutic dosing of strontium ranelate

Repeated supratherapeutic dosing of strontium ranelate

February 20, 2020

Repeated supratherapeutic dosing of strontium ranelate over 15 days does not prolong QTc interval in healthy volunteers. Taubel et al. Br J Clin Pharmacol 2012;74(2): 296-303

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The Power Of Phase I Studies To Detect Clinically Relevant Qtc Prolongation

The Power Of Phase I Studies To Detect Clinically Relevant Qtc Prolongation

February 20, 2020

The Power Of Phase I Studies To Detect Clinically Relevant Qtc Prolongation – Results From A Resampling Simulation Study. Ferber et al. The 35th Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 4-6

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Investigating the effect of intravenous APD421 (Amilsulpride) and the ethnic differences

Investigating the effect of intravenous APD421 (Amilsulpride) and the ethnic differences

February 20, 2020

Investigating the effect of intravenous APD421 (Amilsulpride) and the ethnic differences between Japanese and Caucasians on cardiac conduction. Jorg Taubel · Georg Ferber · Gabriel Fox · Sara Fernandes · Ulrike Lorch · A John Camm. Tokyo, The

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Confirmation of the Cardiac Safety of Rupatadine in a Single Ascending Dose and Multiple Ascending Dose

Confirmation of the Cardiac Safety of Rupatadine in a Single Ascending Dose and Multiple Ascending Dose

February 20, 2020

Confirmation of the Cardiac Safety of Rupatadine in a Single Ascending Dose and Multiple Ascending Dose Study in Japanese Healthy Subjects Using Intensive ECG Assessments. Jorg Taubel · Georg Ferber · Inaki Izuierdo. 2015 Annual Meeting, San

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Late Changes After a Euglycaemic Insulin Clamp

Late Changes After a Euglycaemic Insulin Clamp

February 20, 2020

Late Changes After a Euglycaemic Insulin Clamp Can Lead to Significant Increases in QTcF In Healthy Subjects. Taubel et al. 2012 ACCP Annual Meeting, San Diego 23-25 September 2012

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Comparison of digital 12-lead ECG and digital 12-lead holter ECG

Comparison of digital 12-lead ECG and digital 12-lead holter ECG

February 20, 2020

Comparison of digital 12-lead ECG and digital 12-lead holter ECG recordings in health male subjects. 112th ASCPT Annual Meeting, March 2-5, 2011, Dallas, TX. Poster Number: PI-08, scheduled on 3/3/2011 from 8:00 AM.

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Retrospective Validation using PK-PD modelling of ECG data

Retrospective Validation using PK-PD modelling of ECG data

February 20, 2020

Retrospective Validation using PK-PD modelling of ECG data derived from a Single Ascending Dose study in accordance with the principles of the ICH E14 guideline utilising the effects of a Meal to establish assay sensitivity. 2013 Annual Meeting

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The Impact of Insulin Levels on QTc Interval in Thorough QT Studies

The Impact of Insulin Levels on QTc Interval in Thorough QT Studies

February 20, 2020

The Impact of Insulin Levels on QTc Interval in Thorough QT Studies Conducted in Healthy Subjects. Taubel et al. ACCP Annual Meeting, San Diego 23-25 September 2012

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Moxifloxacin effect on QTc interval

Moxifloxacin effect on QTc interval

February 20, 2020

Moxifloxacin effect on QTc interval in the fed and fasted states in Thorough QT studies. Jorg Taubel MD FFPM. DIA/FDA Cardiovascular Safety in Drug Development: State-of-the-art Assessments, Washington 18th April 2012

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Retrospective analysis of ECG data

Retrospective analysis of ECG data

February 20, 2020

Retrospective analysis of ECG data derived from a four-way cross over study involving a broad spectrum anti-infective agent nitazoxanide. Taubel et al. Pharmacology 2013, London, UK, 17-19 December 2013

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Alternative methods for the confirmation of assay sensitivity in Thorough QT studies

Alternative methods for the confirmation of assay sensitivity in Thorough QT studies

February 20, 2020

Alternative methods for the confirmation of assay sensitivity in Thorough QT studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan. Program

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Sex differences on the effect of moxifloxacin

Sex differences on the effect of moxifloxacin

February 20, 2020

Sex differences on the effect of moxifloxacin – A meta-analysis of five Thorough QT Studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan.

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QT prolongation in healthy Japanese subjects

QT prolongation in healthy Japanese subjects

February 20, 2020

QT prolongation in healthy Japanese subjects receiving moxifloxacin in Thorough QT studies. Taubel et al. The 32nd Annual Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), 1-3 December 2011, Tokyo, Japan. Program

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The 24 Hour Profile of Moxifloxacin Effect on QTc

The 24 Hour Profile of Moxifloxacin Effect on QTc

February 20, 2020

The 24 Hour Profile of Moxifloxacin Effect on QTc – A Reflection of Diurnal Variations – This study aims to define the time course of the effect of moxifloxacin on the QT-interval with continuous Holter data in order to better understand

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Confirmation of the Cardiac Safety of OBE022

Confirmation of the Cardiac Safety of OBE022

February 20, 2020

Confirmation of the Cardiac Safety of OBE022 in a First in Human Study in Healthy Subjects using Intensive ECG Assessments and the Effect of a Meal on QTc to Show Assay Sensitivity – One of the objectives of this first-in-human study was

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Estimation of the Power of the Food Effect on QTc

Estimation of the Power of the Food Effect on QTc

February 20, 2020

Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity. Georg Ferber, PhD, Sara Fernandes, PhD, and Jörg Täubel,MD, FFPM.

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Cardiac Safety of Rupatadine in a Single-Ascending-Dose and Multiple-Ascending-Dose

Cardiac Safety of Rupatadine in a Single-Ascending-Dose and Multiple-Ascending-Dose

February 20, 2020

Cardiac Safety of Rupatadine in a Single-Ascending-Dose and Multiple-Ascending-Dose Study in Healthy Japanese Subjects, Using Intensive Electrocardiogram Assessments – Comparison With the Previous White Caucasian Thorough QT Study

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Comparison of ECG Parameters Using GE Getemed Continuous ECG Holter and MAC-1200 Bedside ECG

Comparison of ECG Parameters Using GE Getemed Continuous ECG Holter and MAC-1200 Bedside ECG

February 20, 2020

Comparison of ECG Parameters Using GE Getemed Continuous ECG Holter and MAC-1200 Bedside ECG. Jörg Täubel, Teresa Del Bianco, Sara Fernandes, Boaz Mendzelevski, Dilshat Djumanov, George Ferber.

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Assessment of C-Peptide Effects on Cardiac Ion Channel Currents

Assessment of C-Peptide Effects on Cardiac Ion Channel Currents

February 20, 2020

Assessment of C-Peptide Effects on Cardiac Ion Channel Currents. J. Täubel, G. Ferber, Teresa del Bianco, S. Fernandes, Dilshat Djumanov, A. John Camm.

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Confirmation of the Cardiac Safety of P218

Confirmation of the Cardiac Safety of P218

February 20, 2020

Confirmation of the Cardiac Safety of P218, a new Investigational Medicinal Product for Prevention of Malaria using Intensive ECG Assessments and the Effect of a Meal on QTC to show Assay Sensitivity.

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A Phase I study to investigate the effects of Clascoterone on QT interval

A Phase I study to investigate the effects of Clascoterone on QT interval

February 20, 2020

A Phase I study to investigate the effects of Clascoterone on QT interval using the effects of a meal on QTc to demonstrate ECG assay sensitivity

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The cardiovascular effects of a meal

The cardiovascular effects of a meal

February 20, 2020

The cardiovascular effects of a meal: assessment of the effects on J-Tpeak and Tpeak-Tend intervals

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Diurnal Profile of the QTc Interval

Diurnal Profile of the QTc Interval

February 20, 2020

Diurnal Profile of the QTc Interval Following Moxifloxacin Administration | J. Täubel , G. Ferber, S. Fernandes, A. John Camm.

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Confirmation of the Cardiac Safety of PGF2α Receptor Antagonist

Confirmation of the Cardiac Safety of PGF2α Receptor Antagonist

February 20, 2020

Confirmation of the Cardiac Safety of PGF2α Receptor Antagonist in a First-In-Human Study in Healthy Subjects, Using Intensive ECG Assessments.

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Influence of calcium blockade on the QT effects of a meal

Influence of calcium blockade on the QT effects of a meal

February 20, 2020

Influence of calcium blockade on the QT effects of a meal – Food ingestion in healthy volunteers leads to an increase in heart rate cardiac stroke volume.

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Concentration-QTC Analysis of a Cholinomimetic Agent

Concentration-QTC Analysis of a Cholinomimetic Agent

February 20, 2020

Concentration-QTC Analysis of a Cholinomimetic Agent Integrated into a Phase 1 – Japanese Bridging Study Using Intensive ECG Assessments

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Do hERG blocking agents further increase

Do hERG blocking agents further increase

February 20, 2020

Do hERG blocking agents further increase the risk of sudden cardiac death in patients with type 1 diabetes?

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The differences between two algorithms

The differences between two algorithms

February 20, 2020

The differences between two algorithms used to measure ECG subintervals in intervention-free, fasted volunteers taking part in an intensive QT study.

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Sex differences in subinterval measurements

Sex differences in subinterval measurements

February 20, 2020

Sex differences in subinterval measurements in intervention-free, fasted ECGs from seven intensive QT studies.

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Sex Hormones and the QT Interval

Sex Hormones and the QT Interval

February 20, 2020

Sex Hormones and the QT Interval: J‐Tpeak and Tpeak‐Tend Assessment and Further Insights Into the Physiological Effects.

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Clinical Pharmacology and Adaptive Early Phase Studies

A randomized, open‑label two‑period crossover pilot study to evaluate the relative bioavailability in the fed state of atovaquone‑proguanil (Atoguanil™) versus atovaquone‑proguanil hydrochloride (Malarone®) in healthy adult participants

July 10, 2024

Atoguanil™ is a novel complex of atovaquone (ATV) and proguanil (PG) with enhanced ATV bioavailability compared to...

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The Value of In-Person Contact in Clinical Trials: A Qualitative Study examining Patient Attitudes towards Trial Visits conducted at a Contract Research Organisation

July 10, 2024

Decentralised clinical trials (DCTs) are those in which “some or all of a clinical trial’s activities can occur at locations other...

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Association for Human Pharmacology in the Pharmaceutical Industry conference 2022: impending change, innovations and future challenges

July 10, 2024

The Association for Human Pharmacology in the Pharmaceutical Industry’s annual meeting focused on current and impending...

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Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials

July 10, 2024

The aim of the study was to assess the viability of auto-injector systems (A-INJ) for preserving investigator blinding in randomized controlled trials (RCT).

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Concentration-QT modelling of the novel DHFR inhibitor P218 in healthy male volunteers

July 10, 2024

Given the increasing emergence of drug resistance in Plasmodium, new antimalarials are urgently required. P218 is an aminopyridine that inhibits...

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Unanticipated CNS Safety Signal in a Placebo-Controlled, Randomized Trial of Co-Administered Atovaquone-Proguanil and Amodiaquine

July 10, 2024

Atovaquone-proguanil (ATV-PG) plus amodiaquine (AQ) has been considered as a potential...

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Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals

July 9, 2024

A number of single-inhaler, fixed-dose, triple combinations are available for the management of...

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A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval Using the Meal Effect to Demonstrate ECG Assay Sensitivity

July 9, 2024

Cortexolone 17α-propionate, also known as clascoterone, is a potent androgen receptor inhibitor intended for the...

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Three steps to writing adaptive study protocols

February 20, 2020

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines. Lorch et al. BMC Medical Research Methodology 2014, 14:84 http://www.biomedcentral.com/1471-2288/14/84

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Early phase clinical trials in the United Kingdom

February 20, 2020

Early phase clinical trials in the United Kingdom. Jorg Taubel, Richmond Pharmacology Ltd and David Rogers, Medicines Evaluation Unit Ltd, Wythenshawe Hospital.

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Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164

February 20, 2020

Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. Jorup et al. BMC Pulmonary Medicine 2014, 14:52

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The practical application of adaptive study design in early phase clinical trials

February 20, 2020

The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Lorch et al. Eur J Clin Pharmacol (2012) 68:543-551

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Rule Britannia – the advantages of conducting first-time-in-human (FTIH) studies in the UK

February 20, 2020

Rule Britannia – the advantages of conducting first-time-in-human (FTIH) studies in the UK compared to other European markets. Taubel J, Berelowitz K, Lorch U. International Clinical Trials P16+ February 2011

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Cizolirtine Citrate (E-4018) in the Treatment of Chronic Neuropathic Pain

February 20, 2020

Cizolirtine Citrate (E-4018) in the Treatment of Chronic Neuropathic Pain. Shembalkar P et al. Curr Med Res Opin 17(4):262-266, 2001

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Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab)

February 20, 2020

Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-inhuman study Zhenhua Xu et al. Br J Clin Pharmacol 2011 72(2) / 270-281

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Effects on 24-Hour Intragastric pH

February 20, 2020

Effects on 24-Hour Intragastric pH: A Comparison of Lansoprazole Administered Nasogastrically in Apple Juice and Pantoprazole Administered Intravenously. Freston J et al. The American Journal of Gastroenterology Vol. 96, No. 7, 2001

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Ascending single-dose study with ACT-280778, a non-dihydropyridine, dual L- and T-type calcium channel blocker

February 20, 2020

Ascending single-dose study with ACT-280778, a non-dihydropyridine, dual L- and T-type calcium channel blocker: safety, tolerability, pharmacokinetics, and effect of food in healthy male subjects. Mueller MS et al. Presented at the American

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How adaptive study design

February 20, 2020

How adaptive study design can enrich an early phase multiple ascending dose study. Lorch et al. 2014 Annual Meeting of the American College of Clinical Pharmacology (ACCP),Atlanta, GA , 14-16 September 2014

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The influence of a low fat diet and hospitalisation on liver function tests

February 20, 2020

The influence of a low fat diet and hospitalisation on liver function tests in healthy Japanese and Caucasian male volunteers resident in a Phase I unit for up to 34 days. 2013 Annual Meeting of the American College of Clinical Pharmacology

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A phase I, randomised single center, open-label parallel group trial to compare the pharmacokinetics

February 20, 2020

A phase I, randomised single center, open-label parallel group trial to compare the pharmacokinetics of NOMAC between healthy female adolescents (aged 14-17 years) and healthy female adults (aged 18-50 years) after single dose administration of

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No clinically relevant effect of TMC125 on the pharmacokinetics

February 20, 2020

No clinically relevant effect of TMC125 on the pharmacokinetics of oral contraceptives. Schöller-Gyüre M et al.

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Analysis of safety, pharmacokinetic and pharmacodynamic data

February 20, 2020

Analysis of safety, pharmacokinetic and pharmacodynamic data derived from a single ascending dose Phase 1 study involving a promising non-cytotoxic anti-cancer agent Sulforadex®. Taubel et al. Pharmacology 2013, London, UK, 17-19 December 2013

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PET500 A Newly Formulated Tetracaine Product

February 20, 2020

PET500 A Newly Formulated Tetracaine Product is Effective in Reducing Penile Sensitivity. Taube et al. Thirty-Ninth Annual Meeting American College of Clinical Pharmacology September 12-14, 2010 Baltimore, Maryland. J Clin Pharmacol, September

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The pharmacokinetic interaction between isoniazid/pyrazinamide and TMC207

February 20, 2020

The pharmacokinetic interaction between isoniazid/pyrazinamide and TMC207, an investigational antimycobacterial agent.

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Clinical Trials

February 20, 2020

Clinical Trials: A Practical Guide to Design, Analysis, and Reporting Crossover Trials Bioequivalence Trials Source and Control of Bias

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Efficient Design of Integrated and Adaptively Interlinked

February 20, 2020

Efficient Design of Integrated and Adaptively Interlinked Early Phase Drug Development Programmes.

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The Pharmacokinetic Interaction of the Selective PGF2α Receptor Antagonist OBE022

February 20, 2020

The Pharmacokinetic Interaction of the Selective PGF2α Receptor Antagonist OBE022 on Co-Administration with MgSO4, Atosiban, Nifedipine or Betamethasone

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Pharmacokinetics and Safety of the Oral Prostaglandin F2 alpha Receptor Antagonist OBE022

February 20, 2020

Pharmacokinetics and Safety of the Oral Prostaglandin F2 alpha Receptor Antagonist OBE022: A First-In-Human Study in Healthy Post-Menopausal Women.

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Practical Risk Management

February 20, 2020

Practical Risk Management for Adaptive Integrated Early Phase Clinical Trials Method.

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Japanese Studies

Lomitapide single-and multiple-dose exposure

February 20, 2020

Lomitapide single-and multiple-dose exposure in Japanese and Caucasian subjects: results of a Phase 1 pharmacokinetic and pharmacodynamic study. Taubel et al. The 46th Annual Scientific Meeting of the Japan Atherosclerosis Society, Tokyo, Japan,

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Early Phase Japanese Bridging Studies

February 20, 2020

Early Phase Japanese Bridging Studies; Their Global Significance and What to Look for when Selecting a Suitable Contract Research Organisation to Conduct these Studies. Berelowitz K et al. International Pharmaceutical Industry; Volume 3, Issue

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Pharmacokinetics, Safety and Tolerability of Rupatadine

February 20, 2020

Pharmacokinetics, Safety and Tolerability of Rupatadine in Healthy Japanese Volunteers. Jorg Taubel · Eva Santamaria. 2015 Annual Meeting of the American College of Clinical Pharmacology, San Francisco, CA; 09/2015

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Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid Blocker

February 20, 2020

Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid Blocker Following Ascending Multiple Doses in Healthy Subjects. Jenkins et al. 20th United European Gastroenterology Week, Amsterdam, The Netherlands, 20-24 Oct 2012. GUT

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Pharmacokinetics and tolerability of sublingual fentanyl

February 20, 2020

Pharmacokinetics and tolerability of sublingual fentanyl in healthy Japanese and Caucasian volunteers: Phase I, open-label, single-dose study. Lorch U et al.

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Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid Blocker

February 20, 2020

Gastric Acid Suppression Effect of TAK-438, A Potassium-Competitive Acid Blocker Following Ascending Single Doses in Healthy Subjects. Sakurai et al. 20th United European Gastroenterology Week, Amsterdam, The Netherlands, 20-24 Oct 2012. GUT

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Similar Rivastigmine Pharmacokinetics and Pharmacodynamics

February 20, 2020

Similar Rivastigmine Pharmacokinetics and Pharmacodynamics in Japanese and White Healthy Participants Following the Application of Novel Rivastigmine Patch. Lefèvre et al. J Clin Pharmacol April 2009 49: 430-443

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The safety, tolerability and pharmacokinetics of AZD5069, a novel CXCR2 antagonist

February 20, 2020

The safety, tolerability and pharmacokinetics of AZD5069, a novel CXCR2 antagonist,in healthy Japanese volunteers. Lorch et al. ERS 2012, September 1-5, Vienna, Austria

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Patient Studies

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of HMB-001 in Participants with Glanzmann Thrombasthenia

December 10, 2024

Glanzmann thrombasthenia (GT) is a rare inherited bleeding disorder characterised by severely impaired platelet aggregatio

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A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation

July 10, 2024

Tumor immunotherapy is designed to control malignancies through the host immune response but requires circumventing...

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Pharmacodynamic Consequences of Administration of VLA-4 Antagonist CDP323 to Multiple Sclerosis Subjects

February 20, 2020

Pharmacodynamic Consequences of Administration of VLA-4 Antagonist CDP323 to Multiple Sclerosis Subjects: A Randomized, Double-Blind Phase 1/2 Study. Wolf et al. PLOS ONE Journal. March 2013 | Volume 8 | Issue 3 | e58438

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Benefits of a Single Versus Multicenter Approach in Early-Phase Patient Studies

February 20, 2020

Benefits of a Single Versus Multicenter Approach in Early-Phase Patient Studies; A Case Study of Multiple Sclerosis Patients. Berelowitz et al. The Monitor Page 21-25. October 2011

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Effect of oseltamivir treatment on anticoagulation

February 20, 2020

Effect of oseltamivir treatment on anticoagulation: a cross-over study in warfarinized patients. Davies B et al. Br J Clin Pharmacol 2010;70(6):834-843. Single centre drug interaction study in 20 patient volunteers on regular warfarin. The study

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An open-label, parallel-group, repeat-dose study

February 20, 2020

An open-label, parallel-group, repeat-dose study to investigate the effects of end-stage renal disease and haemodialysis on the pharmacokinetics of ropinirole. Tompson et al. 13th International Congress of Parkinson’s Disease and Movement

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Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction

February 20, 2020

Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction: A Randomized Crossover Study

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Concentration-Effect Modelling of Blood-Pressure

February 20, 2020

Concentration-Effect Modelling of Blood-Pressure in Early Stage Trials

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Occult Hepatic Steatosis

February 20, 2020

Occult Hepatic Steatosis – How can we distinguish true treatment emerging liver signals from undetected, unrelated liver abnormalities?

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Diurnal and Racial Variance of White Blood Cell Parameters

February 20, 2020

Diurnal and Racial Variance of White Blood Cell Parameters in Early Phase Clinical Trials: A Retrospective Analysis of Pooled Data from Multiple Phase I Trials

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Latest news

Richmond Appoints Lisa Campbell as Director of Regulatory Strategy

April 23, 2025
Richmond Pharmacology is pleased to announce the appointment of Lisa Campbell as Director of Regulatory Strategy
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Von Willebrand Disease Trial – First Stage of Hemab Therapeutics’ Trial Completed and New Patients Invited to Enrol

April 2, 2025
Richmond has completed dosing the first cohort of patients in Velora Pioneer, a phase 1/2 clinical trial investigating Hemab...
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Swiss Biotech Day 2025

5–6 May 2025
Richmond Pharmacology is pleased to confirm our participation at Swiss Biotech Day 2025
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