Clinical trials: QTc Interval
Healthy
A TQT Study of Effect of M2951 on Cardiac Repolarization
The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).
- Trial name
- NCT07214935
- Testing
- Moxifloxacin, M2951 Low Dose, M2951 High Dose
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Cancer
A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval
This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval duration) in subjects with advanced solid tumors.
- Trial name
- NCT01328054
- Testing
- lapatinib
- Where
- 4 sites in United States
- Volunteers
- 58 people
- Sponsor
- GlaxoSmithKline
Schizophrenia
A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019)
The primary purpose of this study to evaluate the effect of a supratherapeutic dose of 80 mg elpipodect on the QT interval corrected for heart rate (QTc interval) and to assess the safety and tolerability of multiple once-daily…
- Trial name
- TQT (NCT05893862)
- Testing
- Elpipodect, Moxifloxacin
- Where
- 4 sites in United States
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Long QT Syndrome
Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care
The purpose of this study is to further develop and evaluate a diagnostic procedure suitable for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome (LQTS) in the primary care environment.
- Trial name
- NCT04441892
- Testing
- QTc Meter
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Mayo Clinic
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited
Advanced Cancer
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.
- Trial name
- NCT00698841
- Testing
- Cetuximab
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- Eli Lilly and Company
Healthy
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization.
- Trial name
- NCT01552928
- Testing
- Anagrelide 0.5 mg, Anagrelide 2.5 mg, Moxifloxacin
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy Volunteers
Cardiac Safety Evaluation of P03277
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.
- Trial name
- NCT03657264
- Testing
- P03277 0.1 mmol/kg, Moxifloxacin 400mg, NaCl 0.9%
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Guerbet
Schizophrenia
A Study of Elpipodect (MK-8189) in Participants With Schizophrenia (MK-8189-014)
The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of elpipodect in participants with schizophrenia.
- Trial name
- NCT05406440
- Testing
- Elpipodect
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy…
- Trial name
- NCT03808298
- Testing
- Balovaptan therapeutic dose Treatment A, Balovaptan supra-therapeutic dose Treatment B, Active control [moxifloxacin] on Day 2 Treatment C
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Congestive Heart Failure
Phase I Study of OPC-61815
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
- Trial name
- NCT03510663
- Testing
- OPC-61815 16mg, OPC-61815 32mg, Moxifloxacin
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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.
Autoimmune Diseases
A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
- Trial name
- NCT04818229
- Testing
- CBP-307, Moxifloxacin (Avelox)
- Where
- 2 sites in United States, Australia
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Connect Biopharma Australia Pty Ltd
Thorough QT/QTc Study
Staccato Loxapine Thorough QT/QTc Study
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.
- Trial name
- NCT00874237
- Testing
- Inhaled loxapine, Oral moxifloxacin
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nova Pneuma Inc.
Solid Tumors
Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization in Patients With Selected Solid Tumors
Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the PM01183 plasma concentration/QTc relationship…
- Trial name
- NCT02451007
- Testing
- lurbinectedin (PM01183)
- Where
- 16 sites in United States, Spain
- Volunteers
- 39 people
- Sponsor
- PharmaMar
Malaria
Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum).
- Trial name
- NCT01614964
- Testing
- AQ-13 Treatment, Coartem Treatment
- Where
- Mali
- Volunteers
- 66 people
- Sponsor
- Tulane University
Cancer, Solid Tumor
Study of Ramucirumab (IMC-1121B) Therapy and Corrected QT (QTc) Interval Changes
The purpose of this study is to determine if Ramucirumab (IMC-1121B) causes prolongation of the QT/QTc interval in participants with advanced cancer.
- Trial name
- NCT01017731
- Testing
- IMC-1121B, Moxifloxacin, Diphenhydramine
- Where
- 7 sites in United States
- Volunteers
- 68 people
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
- Trial name
- NCT00672984
- Testing
- immediate release guanfacine hydrochloride, moxifloxacin
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy Volunteers
A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.
- Trial name
- NCT00926263
- Testing
- CP-751,871, CP-751,871, moxifloxacin, saline
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer