Trials / Completed
CompletedNCT01367509
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
A Phase 1, Open-Label Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This study is evaluating the Pharmacokinetics of MNTX in healthy control subjects and in patients with mild, moderate, or severe renal impairment who do not require hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylnaltrexone (MNTX) |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2005-01-01
- Completion
- 2005-06-01
- First posted
- 2011-06-07
- Last updated
- 2019-11-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01367509. Inclusion in this directory is not an endorsement.