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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802682
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Apalutamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : January 11, 2019
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 11, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apalutamide

Arm Intervention/treatment
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.
Drug: Apalutamide
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.
Other Name: JNJ-56021927 and ARN-509

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.
Drug: Apalutamide
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.
Other Name: JNJ-56021927 and ARN-509




Primary Outcome Measures :
  1. 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 ]
    Cmax is the maximum observed plasma concentration.

  2. Area Under the Plasma Concentration-time Curve From Time 0 to 72 hours (h) (AUC [0-72h] [ 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 ]
    AUC(0-72h) is area under plasma concentration-time curve from time zero to 72 hours.

  3. Area Under the Plasma Concentration-time Curve From Time 0 to 168 hours (AUC[0-168h]) [ 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 ]
    AUC(0-168h) is area under plasma concentration-time curve from time zero to 168 hours.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Approximately 84 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802682


Locations
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Belgium
Clinical Pharmacology Unit
Merksem, Belgium, 2170
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03802682    
Other Study ID Numbers: CR108562
2018-003774-27 ( EudraCT Number )
56021927PCR1024 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes