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NCT01366378 · ClinicalTrials.gov registry record · Phase 1
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
A Phase 1 study of Healthy Adult Subjects, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01366378: Completed Phase 1 study of Healthy Adult Subjects, sponsored by Bausch Health Americas.
NCT01366378 is a Phase 1 study of Healthy Adult Subjects that has completed, run by Bausch Health Americas. The registered enrollment target is 18 participants, below the 38-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366378, a Phase 1 study of Healthy Adult Subjects, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
Primary Outcome
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX
Conditions Studied
Interventions
- DRUG methylnaltrexone
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-02 |
| Phase | Phase 1 |
What the finished NCT01366378 record still lists
NCT01366378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 38-participant average among 3 other Healthy Adult Subjects trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Healthy Adult Subjects appearing as the primary indexed condition, and to 1 intervention - of which methylnaltrexone is the first listed.
NCT01366378 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01366378 about?
NCT01366378 is a clinical study titled "Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX". This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
What is the current status of trial NCT01366378?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2007-01. Estimated completion is 2007-02.
What conditions does trial NCT01366378 study?
This clinical trial studies the following conditions: Healthy Adult Subjects.
What interventions are being tested in trial NCT01366378?
The interventions under investigation include: methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01366378?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366378 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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