A Study of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03802682
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Apalutamide — DRUG
    Participants will receive apalutamide 240 mg as a whole tablets administered orally (Treatment A) or as a dispersed mixture in applesauce (Treatment B) under fasted condition.

Study Details

The purpose of this study is to determine the bioavailability of apalutamide tablets administered orally as dispersed tablets mixed in applesauce relative to whole tablets under fasting conditions in healthy male participants.

Key Dates

Start date
Jan 11, 2019
Status verified
Jan 2025
Primary completion
Apr 11, 2019
Completion
Apr 11, 2019

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Treatment Sequence AB
    Participants will receive a single dose of apalutamide 240 milligram (mg) (4\*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 1 (Treatment A \[reference\]) followed by a single dose of apalutamide 240 mg (4\*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 2 (Treatment B \[test\]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.
  • Experimental: Treatment Sequence BA
    Participants will receive a single dose of apalutamide 240 mg (4\*60 mg tablets) as a dispersed mixture in applesauce under fasted conditions on Day 1 of Treatment Period 1 (Treatment B \[test\]) followed by a single dose of apalutamide 240 mg (4\*60 mg tablets) swallowed whole under fasted conditions on Day 1 of Treatment Period 2 (Treatment A \[reference\]). Study treatment periods will be separated by a washout interval of at least 42 days and no more than 56 days between doses.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1: Predose, 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose ]

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