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NCT01366365 · ClinicalTrials.gov registry record · Phase 1
Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01366365: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01366365 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366365, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.
Primary Outcome
Evaluate the PK of MNTX in healthy adult and healthy elderly male and female human subjects following MNTX administration as a single IV dose, and at steady state during multiple IV doses
Interventions
- DRUG placebo
- DRUG methylnaltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2006-10 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
What the finished NCT01366365 record still lists
NCT01366365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01366365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01366365 about?
NCT01366365 is a clinical study titled "Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide". This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerabilit...
What is the current status of trial NCT01366365?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2006-10. Estimated completion is 2006-11.
What interventions are being tested in trial NCT01366365?
The interventions under investigation include: placebo (DRUG), methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01366365?
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 NCT01366365's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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