Overview

Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group

Status:
Completed

Trial end date:
2012-01-01

Target enrollment:

Participant gender:

Summary

This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects. The study will consist of two treatment arms. Arm A will assess the influence of mild hepatic impairment, and Arm B will assess the influence of moderate hepatic impairment. Data obtained from subjects with hepatic impairment will be compared to data from Body Mass Index (BMI) and age-matched subjects with normal hepatic function.

Phase:

Phase 1

Details

Lead Sponsor:

Astellas Pharma Europe B.V.

Collaborator:

Medivation, Inc.