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NCT01367522 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01367522: Completed Phase 1 study, sponsored by Bausch Health Americas.
NCT01367522 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367522, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and at specified intervals after dosing and the concentration of MNTX will be analyzed.
Primary Outcome
To evaluate the pharmacokinetics of MNTX administered subcutaneously as a single dose in individuals with impaired liver and hepatic function compared to healthy controls.
Interventions
- DRUG SC Methylnaltrexone (MNTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-07 |
| Phase | Phase 1 |
What the finished NCT01367522 record still lists
NCT01367522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which SC Methylnaltrexone (MNTX) is the first listed.
NCT01367522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01367522 about?
NCT01367522 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function". This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and...
What is the current status of trial NCT01367522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-03. Estimated completion is 2004-07.
What interventions are being tested in trial NCT01367522?
The interventions under investigation include: SC Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01367522?
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 NCT01367522's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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