ReviewBritish journal of pharmacology2010
The thorough QT/QTc study 4 years after the implementation of the ICH E14 guidance.
Review in British journal of pharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
64 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Losmapimod concentration-QT relationship in healthy volunteers: meta-analysis of data from six clinical trials.European journal of clinical pharmacology · 2013Pooled it
- A Randomized, Double-Blinded, Placebo-Controlled QTc Study to Evaluate BIA 28-6156 Effect on Cardiac Repolarization in Healthy Volunteers.Clinical pharmacology in drug development · 2026Trial
- Concentration-QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval.CPT: pharmacometrics & systems pharmacology · 2025Trial
- A phase I thorough QT/QTc study evaluating therapeutic and supratherapeutic doses of avacopan in healthy participants.Clinical and translational science · 2024Trial
- No clinically relevant electrocardiogram effects in a randomized TQT study of single therapeutic/supratherapeutic rimegepant doses in healthy adults.Clinical and translational science · 2024Trial
- A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson's Disease.Clinical pharmacology in drug development · 2022Trial
- Phase 1 Study of the Effects of the Tuberculosis Treatment Pretomanid, Alone and in Combination With Moxifloxacin, on the QTc Interval in Healthy Volunteers.Clinical pharmacology in drug development · 2021Trial
- Effect of lurbinectedin on the QTc interval in patients with advanced solid tumors: an exposure-response analysis.Cancer chemotherapy and pharmacology · 2021Trial
- The effect of the glucosylceramide synthase inhibitor lucerastat on cardiac repolarization: results from a thorough QT study in healthy subjects.Orphanet journal of rare diseases · 2020Trial
- Trial
- A Thorough QT Study to Evaluate the Effects of a Supratherapeutic Dose of Sertraline on Cardiac Repolarization in Healthy Subjects.Clinical pharmacology in drug development · 2020Trial
- Revefenacin, a Long-Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo- and Positive-Controlled Thorough QT Study.Clinical pharmacology in drug development · 2020Trial
- Impact of the Norepinephrine Prodrug Droxidopa on the QTc Interval in Healthy Individuals.Clinical pharmacology in drug development · 2018Trial
- Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity.Journal of clinical pharmacology · 2018Trial
- Effect of Therapeutic and Supratherapeutic Doses of Vonoprazan on the QT/QTc Interval in a Phase I Randomized Study in Healthy Subjects.Clinical and translational science · 2017Trial
- Concentration-QT analysis of the randomized, placebo- and moxifloxacin-controlled thorough QT study of umeclidinium monotherapy and umeclidinium/vilanterol combination in healthy subjects.Journal of pharmacokinetics and pharmacodynamics · 2016Trial
- Orally administered moxifloxacin prolongs QTc in healthy Chinese volunteers: a randomized, single-blind, crossover study.Acta pharmacologica Sinica · 2015Trial
- Randomized, Controlled, Thorough QT/QTc Study Shows Absence of QT Prolongation with Luseogliflozin in Healthy Japanese Subjects.PloS one · 2015Trial
- Trial
- A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects.British journal of clinical pharmacology · 2014Trial
4 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The ICH E14 guidance on how to clinically assess a new drug's liability to prolong the QT interval was adopted in May 2005. A centre-piece of the guidance was the establishment of one single trial, the 'thorough QT/QTc study', intended to confidently identify drugs that may cause QT prolongation. Initially perceived as a great challenge, this study has rapidly become a standard component of all clinical development programs for new molecular entities. The study is normally conducted in healthy volunteers, includes both a positive and a negative (placebo) control and is stringently powered to exclude an effect on the QTc interval exceeding 10 ms. The E14 guidance was intentionally not very prescriptive and allowed sponsors and service providers to explore new methodologies. This has allowed for a rapid development of new methods during the first years after the guidance's implementation, such as computer-assisted algorithms for QT measurements. Regulators have worked in close collaboration with pharmaceutical industry to set standards for the design and conduct of the 'thorough QT/QTc study', which therefore has evolved as a key component of cardiac safety assessment of new drugs. This paper summarizes the requirements on the 'thorough QT/QTc study' with emphasis on the standard that has evolved based on interactions between regulators and sponsors and the experience from a large number of completed studies.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.