drugset / Trial / NCT01367522
Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2004-07
- Completion
- 2004-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | — | Subcutaneous |