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Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function

Liver Dysfunction Clinical Trial

Official title:
A Phase 1, Open-Label, Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Volunteers With Impaired Hepatic Function

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01367522
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase Phase 1
Start date March 2004
Completion date July 2004
View Details
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