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

Part of paid clinical trials in Homestead, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04154774
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Apalutamide — DRUG
    Apalutamide will be administered orally.

Study Details

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.

Key Dates

Start date
Nov 7, 2019
Status verified
Jul 2025
Primary completion
Feb 10, 2025
Completion
Feb 10, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Area Under Concentration-time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of Apalutamide [ Time Frame: Up to Day 57 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Homestead Associates in Research IncHomesteadFlorida33033-
Orlando Clinical Research CenterOrlandoFlorida32809-
Genesis Clinical ResearchTampaFlorida33603-
VGR & NOCCR - KnoxvilleKnoxvilleTennessee37920-

Find similar trials in Homestead, FL

By research site
Homestead Associates in Research Inc· Homestead, FLOrlando Clinical Research Center· Orlando, FLGenesis Clinical Research· Tampa, FLVGR & NOCCR - Knoxville· Knoxville, TN

Related Studies