Trials / Completed
CompletedNCT01367535
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SC Methylnaltrexone (MNTX) | |
| DRUG | IV Methylnaltrexone (MNTX) | |
| DRUG | Oral Paroxetine | |
| DRUG | SC Placebo |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2006-08-01
- Completion
- 2006-08-01
- First posted
- 2011-06-07
- Last updated
- 2019-11-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01367535. Inclusion in this directory is not an endorsement.