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NCT01367483 · ClinicalTrials.gov registry record · Phase 1
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX
A Phase 1 study of Healthy Male Volunteers, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT01367483: Completed Phase 1 study of Healthy Male Volunteers, sponsored by Bausch Health Americas.
NCT01367483 is a Phase 1 study of Healthy Male Volunteers that has completed, run by Bausch Health Americas. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367483, a Phase 1 study of Healthy Male Volunteers, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.
Primary Outcome
To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.
Conditions Studied
Interventions
- DRUG IV methylnaltrexone (MNTX)
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2005-06 |
| Est. Completion | 2005-06 |
| Phase | Phase 1 |
What the finished NCT01367483 record still lists
NCT01367483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy Male Volunteers appearing as the primary indexed condition, and to 1 intervention - of which IV methylnaltrexone (MNTX) is the first listed.
NCT01367483 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01367483 about?
NCT01367483 is a clinical study titled "Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX". This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of pos...
What is the current status of trial NCT01367483?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2005-06. Estimated completion is 2005-06.
What conditions does trial NCT01367483 study?
This clinical trial studies the following conditions: Healthy Male Volunteers.
What interventions are being tested in trial NCT01367483?
The interventions under investigation include: IV methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01367483?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01367483 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 NCT01367483's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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