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NCT02735603 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
A Phase 1 study, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT02735603: Completed Phase 1 study, sponsored by Orexigen Therapeutics.
NCT02735603 is a Phase 1 study that has completed, run by Orexigen Therapeutics. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02735603, a Phase 1 study, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.
Primary Outcome
QT and RR intervals will be recorded using ECG machines. Fridericia correction method is calculated by dividing QT interval by the cube root of the RR interval: QTcF = QT/RR\^1/3.
Interventions
- OTHER Placebo
- DRUG Moxifloxacin
- DRUG Naltrexone HCl/bupropion HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2016-04 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT02735603 record still lists
NCT02735603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02735603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02735603 about?
NCT02735603 is a clinical study titled "Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants". The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.
What is the current status of trial NCT02735603?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2016-04. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02735603?
The interventions under investigation include: Placebo (OTHER), Moxifloxacin (DRUG), Naltrexone HCl/bupropion HCl (DRUG).
Who is sponsoring clinical trial NCT02735603?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02735603's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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