Clinical trials: QTc Interval
Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL)
An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients
The purpose of this study is to assess the effects of CPX-351 on cardiac repolarization, assess plasma drug levels, asses serum copper levels, and assess drug levels in urine.
- Conditions
- Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS)
- Trial name
- NCT02238925
- Testing
- CPX-351
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Jazz Pharmaceuticals
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.
Cardiotoxicity
Staccato Prochlorperazine Thorough QT/QTc
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
- Trial name
- NCT00543062
- Testing
- Inhaled prochlorperazine 5 mg, Inhaled prochlorperazine 10 mg, Oral moxifloxacin
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alexza Pharmaceuticals, Inc.
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
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
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
Healthy Study Participants
A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
The purpose of the study is to evaluate the effects on cardiac repolarization of high-dose padsevonil (PSL) in comparison to placebo in healthy study participants.
- Trial name
- NCT04126343
- Testing
- Padsevonil, Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
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
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.
QT Intervals Changes, QTc Intervals Changes
Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults
The primary objective of this study is to assess the effect of a single therapeutic (50 mg) oral dose of omecamtiv mecarbil (OM) on the QT interval / QT interval corrected for heart rate (QTc), relative to placebo, in healthy…
- Trial name
- NCT04175808
- Testing
- Omecamtiv Mecarbil (OM), Moxifloxacin
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Cytokinetics
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
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
Solid Cancers
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with…
- Trial name
- NCT00927589
- Testing
- carboplatin, docetaxel, trastuzumab
- Where
- 20 sites in United States
- Volunteers
- 59 people
- Sponsor
- Genentech, Inc.
Healthy
CP-690,550 Thorough QTc Study
ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development.
- Trial name
- NCT01743677
- Testing
- CP-690,550, Moxifloxacin
- Where
- 2 sites in Belgium, Singapore
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
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 Adult Subjects
A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)
- Trial name
- NCT04029090
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shionogi
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
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
Electrocardiogram Repolarisation Abnormality, Gonococcal Infection
Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male and Female Subjects
The Phase I Thorough QT/QTc (TQT) study will be performed in a single center, the Vince \& Associates Clinical Research, Inc., clinical trials unit (CTU), in 72 healthy male or female subjects, aged 18 to 45 years inclusive, to…
- Trial name
- NCT03613649
- Testing
- AZD0914, Moxifloxacin
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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