Clinical trials: Evaluation of QTc Interval
Healthy Volunteer
A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval
This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2).
- Trial name
- NCT02165332
- Testing
- Part 1: SAD RO7033877, Part 2: Treatment A, RO7033877, Part 2: Treatment B, RO7033877
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumor
PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates
Study 516-010 is an open-label Phase 1, drug-drug interaction and QTc study evaluating the effect of sitravatinib on probe substrates for CYP450 enzymes and BCRP and P-gp transporters.
- Trial name
- NCT04887194
- Testing
- Sitravatinib, Warfarin, Dextromethorphan
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Mirati Therapeutics Inc.
Influenza, Human
A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers
Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments.
- Trial name
- NCT01353729
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cancer
A Study to Evaluate the Effect of Repeat Oral Dosing of GSK2118436 on Cardiac Repolarization in Subjects With V600 BRAF Mutation-Positive Tumors
This is a Phase I, multicenter, 2-part study with Part 1 designed as a safety lead-in and Part 2 designed to evaluate the effect of GSK2118436 on cardiac repolarization (corrected QT interval [QTc] duration) as compared with…
- Trial name
- NCT01738451
- Testing
- GSK2118436 75 mg
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 50 people
- Sponsor
- GlaxoSmithKline
Smoking Cessation
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.
- Trial name
- NCT05566288
- Testing
- Cytisinicline, Moxifloxacin
- Where
- Portugal
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
QT/QTc
Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization
THOROUGH QT/QTc STUDY TO EVALUATE THE EFFECTS OF ECOPIPAM (EBS-101) ON CARDIAC REPOLARIZATION
- Trial name
- NCT05841160
- Testing
- Ecopipam Hydrochloride, Moxifloxacin
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Emalex Biosciences Inc.
Hypertension, Mineralocorticoid Receptor Antagonist
The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.
- Trial name
- NCT04019652
- Testing
- CS-3150, Moxifloxacin
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Diabetes, Healthy
A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects
This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.
- Trial name
- NCT02064348
- Testing
- semaglutide, moxifloxacin
- Where
- Germany
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012)
Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often.
- Trial name
- NCT07305831
- Testing
- Ulonivirine, Moxifloxacin
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects
This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug development.
- Trial name
- NCT01941511
- Testing
- Rivipansel
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
Healthy Volunteer
Definitive QT Study With MT-8554
This is a study to definitively assess the effects of MT 8554, adjusted for placebo, on the change of the QT interval corrected for heart rate (HR) using the Fridericia formula (QTcF) from Baseline in healthy adult subjects
- Trial name
- MT-8554 DQT (NCT03471130)
- Testing
- MT-8554 Low dose, MT-8554 High dose
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma America, Inc.
Healthy
Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One will be used to identify a safe supratherapeutic dose to be used in the TQT study (Phase Two).
- Trial name
- NCT03564158
- Testing
- meropenem-vaborbactam, Moxifloxacin
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Infections, Bacterial
A Single Center Four Part Study in Healthy Adult Subjects to Evaluate: the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose and Repeat Escalating Oral Doses of GSK945237; the Effect of Linezolid on Hematology Safety Parameters; and the Effects of GSK945237 and Moxifloxacin on QTc.
GSK945237 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK945237 has demonstrated in vitro and in vivo activity against Gram positive [including methicillin resistant Staphylococcus aureus…
- Trial name
- NCT01039610
- Testing
- GSK945237, Linezolid, Moxifloxacin
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Coronary Syndrome
A Study to Evaluate the Effect of Losmapimod on Cardiac Conduction as Compared to Placebo and Moxifloxacin
This will be a double-blind, 4-period, randomized, cross-over study conducted in healthy adult subjects. The purpose of this study is to characterize the effect of orally administered losmapimod on the electrocardiogram (ECG)…
- Trial name
- NCT01756495
- Testing
- Losmapimod, Moxifloxacin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy Volunteers
This study will evaluate the effects of ALKS 5461 on QT intervals in healthy volunteers as well as evaluate the safety and tolerability of ALKS 5461.
- Trial name
- NCT02479308
- Testing
- Moxifloxacin, ALKS 5461
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Leukaemia, Lymphocytic, Chronic
Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects
Ofatumumab is a fully-human monoclonal antibody that exhibits high binding affinity to an antigen on the surface of B lymphocytes.
- Trial name
- NCT01110031
- Testing
- Ofatumumab
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Healthy
ANX-188 Thorough QT/QTc Study in Healthy Volunteers
This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval…
- Trial name
- NCT01790087
- Testing
- ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose, Saline
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Mast Therapeutics, Inc.
Postoperative Pain
Phase 1 Thorough QT Study in Young Healthy Volunteers
A reduction in the postoperative need for opioids to enhance the recovery process and increase patient postoperative satisfaction.
- Trial name
- TQT (NCT00485667)
- Testing
- SKY0402, Moxifloxacin 400mg
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain
A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its…
- Trial name
- NCT05818852
- Testing
- VX-548, Moxifloxacin
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Restless Legs Syndrome
A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive control, moxifloxacin.
- Trial name
- NCT01516372
- Testing
- GEn 1200mg, Gen 6000 mg, Moxifloxacin
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- XenoPort, Inc.