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NCT03606057 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 188
- Enrollment target
NCT03606057: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03606057 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 188 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03606057, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 188 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects on placebo-corrected change from baseline QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered subcutaneously once weekly.
Primary Outcome
Placebo-corrected change from baseline in QT interval corrected for individual heart rate (QTcI) on day 26 time-matched time points will be determined. The mean change from baseline in QTcI for participants who receive placebo will be subtracted from the mean change from baseline in QTcI for participants on JNJ-64565111 at the same time point to generate placebo-corrected change from baseline in QTcI, which will be presented.
Interventions
- DRUG Moxifloxacin
- DRUG JNJ-64565111
- DRUG Moxifloxacin-matching Placebo
- DRUG JNJ-64565111-matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 1 |
What the finished NCT03606057 record still lists
NCT03606057 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (213% higher).
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT03606057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03606057 about?
NCT03606057 is a clinical study titled "A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)". The purpose of this study is to assess the effects on placebo-corrected change from baseline QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise healthy overweight/obese ...
What is the current status of trial NCT03606057?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 188 participants. The study started on 2018-07-13. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT03606057?
The interventions under investigation include: Moxifloxacin (DRUG), JNJ-64565111 (DRUG), Moxifloxacin-matching Placebo (DRUG), JNJ-64565111-matching Placebo (DRUG).
Who is sponsoring clinical trial NCT03606057?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03606057's enrollment target sits among peer trials
188 289th of 2000 higher than 1,711 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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