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

NCT04154774 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10871456021927PCR1026
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide

  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.

  Up to Day 57

• Area Under Concentration-time Curve from Time 0 to the Time of the Last Concentration (AUC[0-last]) of Apalutamide

  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.

  Up to Day 57

• Peak Plasma Concentration (Cmax) of Apalutamide

  Cmax is defined as peak observed plasma concentration of the drug.

  Up to Day 57

Secondary Outcomes (1)

• Number of Participants with Adverse Event as a Measure of Safety and Tolerability

  Up to 78 days

Study Arms (2)

Group 1: Participants with Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive single oral dose of apalutamide on Day 1 under fasted condition.

Drug: Apalutamide

Group 2: Participants with Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive single oral dose of apalutamide on Day 1 under fasted condition.

Drug: Apalutamide

Interventions

Apalutamide DRUG

Apalutamide will be administered orally.

Also known as: JNJ-56021927

Group 1: Participants with Severe Hepatic Impairment; Group 2: Participants with Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Homestead Associates in Research Inc

Homestead, Florida, 33033, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

VGR & NOCCR - Knoxville

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Interventions

apalutamide

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 6, 2019
• Study Start: November 7, 2019
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (4)