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NCT01367535 · ClinicalTrials.gov registry record · Phase 1
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01367535: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01367535 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367535, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
Primary Outcome
The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.
Interventions
- DRUG SC Placebo
- DRUG IV Methylnaltrexone (MNTX)
- DRUG SC Methylnaltrexone (MNTX)
- DRUG Oral Paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
What the finished NCT01367535 record still lists
NCT01367535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which SC Placebo is the first listed.
NCT01367535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01367535 about?
NCT01367535 is a clinical study titled "Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan". This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
What is the current status of trial NCT01367535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-03. Estimated completion is 2006-08.
What interventions are being tested in trial NCT01367535?
The interventions under investigation include: SC Placebo (DRUG), IV Methylnaltrexone (MNTX) (DRUG), SC Methylnaltrexone (MNTX) (DRUG), Oral Paroxetine (DRUG).
Who is sponsoring clinical trial NCT01367535?
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 NCT01367535's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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