Severe Hepatic Impairment Clinical Trial
Official title:
A Phase 1, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Enzalutamide in Male Subjects With Severe Hepatic Impairment and Normal Hepatic Function
The influence of severely diminished liver function on the metabolism, safety, and tolerability of a single oral dose of enzalutamide in a group of 8 men. The results are compared to the data gained from 8 age- and BMI-matched men with normal liver function.
Screening takes place between Day -22 and Day -2, and subjects are admitted to the clinic on
Day -1. Each subject receives a single oral dose of enzalutamide on Day 1, under fasted
conditions. They are discharged on Day 7; ambulant visits take place until Day 50. An End of
Study Visit (ESV) occurs 7-10 days after the last PK sampling or early withdrawal.
Full PK profiles are obtained for enzalutamide, metabolite 1 of enzalutamide (M1) and
metabolite 2 of enzalutamide (M2) up to 1176 hours (Day 50) after administration.
Safety assessments are performed throughout the study. For subjects with severe hepatic
impairment, additional Child-Pugh classification and laboratory safety tests (including
liver function tests) are performed regularly after administration.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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