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

NCT03802682 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1085622018-003774-2756021927PCR1024
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax)

  Cmax is the maximum observed plasma concentration.

  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

• Area Under the Plasma Concentration-time Curve From Time 0 to 72 hours (h) (AUC [0-72h]

  AUC(0-72h) is area under plasma concentration-time curve from time zero to 72 hours.

  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

• Area Under the Plasma Concentration-time Curve From Time 0 to 168 hours (AUC[0-168h])

  AUC(0-168h) is area under plasma concentration-time curve from time zero to 168 hours.

  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

Secondary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Approximately 84 days

Study Arms (2)

Treatment Sequence AB

EXPERIMENTAL

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.

Drug: Apalutamide

Treatment Sequence BA

EXPERIMENTAL

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.

Drug: Apalutamide

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.

Also known as: JNJ-56021927 and ARN-509

Treatment Sequence AB; Treatment Sequence BA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study drug
• Body mass index (BMI; weight \[Kilogram{kg}/height\^2 \[meter {m}\^2\]) between 18 and 30 kg/m\^2 (inclusive), and body weight not less than 50 kg
• Blood pressure (after the participant is sitting for at least 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
• Nonsmoker within the last 2 months (calculated from the first dosing)
• A 12-lead Electrocardiogram (ECG) at screening consistent with normal cardiac conduction and function, including: (1) Sinus rhythm; (2) Pulse rate between 40 and 100 beats per minute (bpm); (3) QTc interval less than or equal to (\<=) 450 milliseconds (ms) (corrected Fridericia; QTcF); (4) QRS interval of less than (\<) 120 ms; (5) PR interval \<210 ms; and (6) Morphology consistent with healthy cardiac conduction and function

You may not qualify if:

• Clinically significant abnormal values for hematology or clinical chemistry at screening or at admission to the study center as deemed appropriate by the investigator
• Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator
• Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food including to excipients of apalutamide or to apple or applesauce
• History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, within 14 days before the first dose of the study drug is scheduled until completion of the study

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Related Links

• A Randomized, Open-label, Two-way, Crossover Study to Evaluate the Relative Bioavailability of Apalutamide Administered Orally as Whole Tablets and as a Mixture in Applesauce in Healthy Subjects

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 14, 2019
• Study Start: January 11, 2019
• Primary Completion: April 11, 2019
• Study Completion: April 11, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)