Clinical trials: Drug-induced QT Prolongation
Long QT Syndrome
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults
This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.
- Trial name
- NCT02365532
- Testing
- GS-6615, Dofetilide
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Long QT Syndrome, Abnormalities, Drug-Induced
Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening
This research will determine if: 1) Oral progesterone attenuates drug-induced QT interval, J-Tpeak and Tpeak-Tend lengthening in postmenopausal women 50 years of age or older, and 2) Transdermal testosterone attenuates…
- Trial name
- NCT04675788
- Testing
- Progesterone, Ibutilide, Testosterone
- Where
- 3 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indiana University
Drug-induced QT Prolongation, Pharmacokinetics
Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
The primary objective of this research study is to test the hypothesis that late sodium current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium channel blocking drugs (dofetilide) on…
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT02308748
- Testing
- Dofetilide, Mexiletine, Lidocaine
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Long QT Syndrome
Influence of Testosterone Administration on Drug-Induced QT Interval Prolongation and Torsades de Pointes
Torsades de pointes (TdP) is a potentially fatal ventricular arrhythmia associated with corrected QT (QTc) interval prolongation.
- Trial name
- NCT02513940
- Testing
- Testosterone, Progesterone, Ibutilide
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Indiana University
Prolonged QT Interval in EKG and Sudden Death
Influence of Progesterone Administration on Drug-Induced QT Interval Lengthening
Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the…
- Trial name
- NCT01929083
- Testing
- Progesterone, Ibutilide
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Indiana University
Long QT Syndrome, Abnormalities, Drug-Induced
Reducing the Risk of Drug-Induced QT Interval Lengthening in Women
This research will determine if oral progesterone attenuates drug-induced QT interval lengthening in a) Postmenopausal women 50 years of age or older, and b) Premenopausal women studied during the ovulation phase of the menstrual…
- Trial name
- NCT03834883
- Testing
- Progesterone, Ibutilide
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Indiana University
Cardiology: RR / QT
Selections of Subjects With Important Changes in Their Cardiac Repolarization Parameters for the Procurement of Skin and Blood Samples
The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and…
- Trial name
- iQTEST (NCT01338441)
- Testing
- Erythromycin
- Where
- France
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Ectycell SASU
Drug-induced QT Prolongation, Pharmacokinetics
CiPA Phase 1 ECG Biomarker Validation Study
This study will assess whether exposure response analysis of the electrocardiographic QTc and J-Tpeakc intervals in Phase 1 clinical pharmacology studies can be used to confirm that drugs that predominantly block the potassium…
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT03070470
- Testing
- Ranolazine, Verapamil, Lopinavir / Ritonavir
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Drug-induced QT Prolongation, Pharmacokinetics
Electrophysiological Effects of Potential QT Prolonging Drugs
Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the QT interval through clinical studies. This requirement stems from the increased TdP risk QT interval prolongation can cause.
- Conditions
- Drug-induced QT Prolongation, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT05716854
- Testing
- Clarithromycin, Pimozide, Moxifloxacin
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Food and Drug Administration (FDA)
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Cardiac Toxicity
Race Difference Moxifloxacin-induced QT Prolongation Between Healthy Chinese and Caucasian Volunteers
A double-center, randomized, double-blinded, 2-way crossover, placebo-controlled Study: Comparison of single oral dose 400mg Moxifloxacin-induced QT prolongation between healthy Chinese volunteers and Caucasian Volunteers Study…
- Trial name
- NCT02119091
- Testing
- Moxifloxacin
- Where
- 2 sites in United States, China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Haiyan Li