A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants … (NCT04154774) | Clinical Trial Compass
CompletedPhase 1
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
United States18 participantsStarted 2019-11-07
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexMALE
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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 hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
* Participants with normal hepatic function must be in good health with no clinically significant findings from medical history, physical examination, vital signs, and laboratory evaluation, unless deemed not clinically significant by the investigator
* Participants with normal hepatic function must have serum creatinine within normal limits and Creatinine Clearance (CrCL) greater than (\>) 60 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2) as calculated per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation
* Participants with severe hepatic impairment must have a total Child-Pugh score of 10 to 15 inclusive, as determined by the investigator during screening and on Day -1 prior to study drug administration. Source documents to substantiate the clinical diagnosis (for example, ultrasonography, liver biopsy, liver/spleen scan, laboratory results or clinical findings), and medical history will be reviewed and signed by the investigator
* Participants with severe hepatic impairment must have CrCL \>= 45 mL/min/1.73 m\^2 as calculated per CKD-EPI Creatinine …
What they're measuring
1
Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide
Timeframe: Up to Day 57
2
Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide