A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Apalutamide

• Registration Number: NCT04154774
• Lead Sponsor: Janssen Research & Development, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Study Start: 2019-11-07
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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 Equation

Exclusion Criteria

• Use of thyroid hormone replacement therapy
• Participants with normal hepatic function with presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function
• Participants with normal hepatic function who have Hepatitis A immunoglobulin M positivity, Hepatitis B surface antigen (HBsAg) positivity, positive serology for Hepatitis B or Hepatitis C antibodies. Hepatitis B surface antibody positivity is not exclusionary if participant can provide evidence of Hepatitis B vaccination
• Participants with severe hepatic impairment who have acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the judgment of either the investigator or the sponsor's medical monitor
• Participants with severe hepatic impairment previously diagnosed with hepatocellular carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Participants with Severe Hepatic Impairment	Apalutamide	Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition.
Group 2: Participants with Normal Hepatic Function	Apalutamide	Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition.

Primary Outcome Measures

Name	Time	Method
Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide	Up to Day 57	AUC(0-last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of apalutamide calculated by linear-linear trapezoidal summation.
Peak Plasma Concentration (Cmax) of Apalutamide	Up to Day 57	Cmax is defined as peak observed plasma concentration of the drug.
Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide	Up to Day 57	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Event as a Measure of Safety and Tolerability	Up to 78 days	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Trial Locations

Locations (4)

Homestead Associates in Research Inc; 🇺🇸 Homestead, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Genesis Clinical Research; 🇺🇸 Tampa, Florida, United States

VGR & NOCCR - Knoxville; 🇺🇸 Knoxville, Tennessee, United States