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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04154774
Collaborator
(none)
16
Enrollment
3
Locations
2
Arms
35.2
Anticipated Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 7, 2019
Anticipated Primary Completion Date :
Oct 14, 2022
Anticipated Study Completion Date :
Oct 14, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group 1: Participants with Severe Hepatic Impairment

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

Drug: Apalutamide
Apalutamide will be administered orally.
Other Names:
  • JNJ-56021927
  • Experimental: Group 2: Participants with Normal Hepatic Function

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

    Drug: Apalutamide
    Apalutamide will be administered orally.
    Other Names:
  • JNJ-56021927
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Peak Plasma Concentration (Cmax) of Apalutamide [Up to Day 57]

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

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts 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:
    • Any participant with screening thyroid stimulating hormone (TSH) level > upper limit of normal (ULN)

    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Orlando Clinical Research CenterOrlandoFloridaUnited States32809
    2VGR & NOCCR - KnoxvilleKnoxvilleTennesseeUnited States37920
    3FDI Clinical ResearchSan JuanPuerto Rico00927

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04154774
    Other Study ID Numbers:
    • CR108714
    • 56021927PCR1026
    First Posted:
    Nov 6, 2019
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 25, 2022