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NCT01363323 · ClinicalTrials.gov registry record · Phase 1
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 546
- Enrollment target
NCT01363323: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01363323 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 546 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (810% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363323, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 546 participants
- Enrollment target
Study Summary
This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to placebo.
Primary Outcome
The primary objective of the study is to compare the effects of clinical and supratherapeutic doses of MNTX with the effects of placebo on QTcI duration in healthy volunteers.
Interventions
- DRUG Placebo
- DRUG Moxifloxacin
- DRUG Methylnaltrexone (MNTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 546 participants |
| Start Date | 2004-11 |
| Est. Completion | 2005-02 |
| Phase | Phase 1 |
What the finished NCT01363323 record still lists
NCT01363323 is an interventional study that assigns participants to a tested intervention. The registered 546 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 (810% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01363323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363323 about?
NCT01363323 is a clinical study titled "Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization". This study will employ a single-center, randomized, double-blind parallel-group design for MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained after single clinical and suprat...
What is the current status of trial NCT01363323?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 546 participants. The study started on 2004-11. Estimated completion is 2005-02.
What interventions are being tested in trial NCT01363323?
The interventions under investigation include: Placebo (DRUG), Moxifloxacin (DRUG), Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01363323?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363323's enrollment target sits among peer trials
546 35th of 2000 higher than 1,966 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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