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A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of Apalutamide in Subjects With Severe Hepatic Impairment Compared With Subjects With Normal Hepatic Function

NCT04154774•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

MALE

Healthy Volunteers

Yes

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

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

Key Dates

Start Date

November 7, 2019

Primary Completion Date

February 10, 2025

Completion Date

February 10, 2025

Last Updated

July 20, 2025

Enrollment

ACTUAL participants

Conditions

Hepatic Impairment

Interventions

Apalutamide

DRUG

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

NCT07324616

Hepatic Impairment (HI)

View study

RECRUITINGPHASE1

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

NCT04271488

Hepatic Impairment

View study

RECRUITINGPHASE1

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

A Varegacestat Hepatic Impairment Study

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004