A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
Last Updated August 28, 2024
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CR108714
OVERVIEW
-
Sexes Eligible for Study
male -
Age
years -
Phase
phase 11 -
Sites
Sites -
Status
Recruiting
SUMMARY
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
CONDITIONS
- Hepatic Impairment
ELIGIBILITY
Inclusion Criteria:
* Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 (for participants with severe hepatic impairment) where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepati
DETAILS
LOCATIONS
Country (1) | City or Province (4) | Status |
United States | Homestead Homestead Associates in Research Inc |
RECRUITING
|
United States | Orlando Orlando Clinical Research Center |
COMPLETED
|
United States | Tampa Genesis Clinical Research |
RECRUITING
|
United States | Knoxville VGR & NOCCR - Knoxville |
RECRUITING
|
25.46872, -80.47756
28.53834, -81.37924
27.94752, -82.45843
35.96064, -83.92074
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