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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 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG SC Methylnaltrexone (MNTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-03 |
| Est. Completion | 2004-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01367522
The ClinicalTrials.gov registry entry for NCT01367522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SC Methylnaltrexone (MNTX) is the first listed.
NCT01367522 reports 0 study locations.
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.
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