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NCT01366339 · ClinicalTrials.gov registry record · Phase 1
Tolerance and Pharmacokinetics Study of MNTX Tablets
A Phase 1 study of Normal Healthy Volunteers, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01366339: Completed Phase 1 study of Normal Healthy Volunteers, sponsored by Bausch Health Americas.
NCT01366339 is a Phase 1 study of Normal Healthy Volunteers that has completed, run by Bausch Health Americas. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366339, a Phase 1 study of Normal Healthy Volunteers, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
Primary Outcome
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Conditions Studied
Interventions
- DRUG Oral placebo
- DRUG Oral methylnaltrexone
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2003-10 |
| Est. Completion | 2003-12 |
| Phase | Phase 1 |
What the finished NCT01366339 record still lists
NCT01366339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Normal Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Oral placebo is the first listed.
NCT01366339 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01366339 about?
NCT01366339 is a clinical study titled "Tolerance and Pharmacokinetics Study of MNTX Tablets". This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an...
What is the current status of trial NCT01366339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2003-10. Estimated completion is 2003-12.
What conditions does trial NCT01366339 study?
This clinical trial studies the following conditions: Normal Healthy Volunteers.
What interventions are being tested in trial NCT01366339?
The interventions under investigation include: Oral placebo (DRUG), Oral methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01366339?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366339 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01366339's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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