Clinical trials: Evaluation of QTc Interval
- Condition Evaluation of QTc Interval
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
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
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
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 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
Malignant Neoplasm of Breast
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
This study will look at the effect on the QTc interval and pharmacokinetics after multiple dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
- Trial name
- NCT03366428
- Testing
- DS-8201a
- Where
- 7 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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.
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
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
Advanced Solid Tumors
Effect of Sapanisertib (MLN0128) on the QTc Interval in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the effect of a single dose of 40 mg sapanisertib (MLN0128) on the electrocardiographic QT/QTc interval in participants with advanced solid tumors.
- Trial name
- NCT02197572
- Testing
- Sapanisertib
- Where
- 5 sites in United States
- Volunteers
- 44 people
- Sponsor
- Calithera Biosciences, Inc
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
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
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
Schizophrenia, Schizoaffective Disorder
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects.
- Trial name
- NCT01423916
- Testing
- OPC-34712 (4mg), Moxifloxacin, OPC-34712 (12mg)
- Where
- 8 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Advanced Solid Neoplasm
A Study to Evaluate the Effects of Pevonedistat on the Corrected QT (QTc) Interval in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the effects of 25 and 50 milligram per square meter (mg/m^2) pevonedistat on the Fridericia corrected QT interval (QTcF) of the electrocardiogram (ECG).
- Trial name
- NCT03330106
- Testing
- Pevonedistat, Docetaxel, Carboplatin
- Where
- 8 sites in United States
- Volunteers
- 68 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Schizophrenia
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
This 4-panel study will evaluate the safety, tolerability, pharmacokinetics (PK) and corrected QT interval (QTc) effect of MK-8189 versus placebo, as monotherapy in healthy participants (Panel A) including those of Japanese…
- Trial name
- MDCS (NCT03565068)
- Testing
- MK-8189, Background AAP Therapy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Bacterial Infections
A Study To Assess The Effect Of Linezolid On QTc Interval
The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG readings) which could predispose patients to ventricular arrhythmias. This study is conducted to satisfy this requirement.
- Trial name
- NCT00795145
- Testing
- Linezolid 900 mg, Linezolid 1200 mg, Linezolid 600 mg
- Where
- Singapore
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dyslipidemias
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in…
- Trial name
- NCT03577275
- Testing
- NST-4016 600mg, Moxifloxacin 400mg, NST-4016 2000mg
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- NorthSea Therapeutics B.V.
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.