Bioavailability Study of 3 Tablet Formulations vs. Capsule Formulation of JNJ-56021927 in Fasting Healthy Male Participants

NCT ID: NCT02160756

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-11-30

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK - the study of the way a drug enters and leaves the blood and tissues over time) and relative bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-56021927, when administered as 3 tablet formulations (test) compared with JNJ-54781532 softgel capsule formulation (reference) in healthy male participants under fasted conditions at a single dose of 240 milligram (mg).

Detailed Description

This is a randomized (study medication assigned to participants by chance), open-label (all people know the identity of the intervention), single-center, 4-treatment, parallel design (a medical research study comparing the response in two or more groups of participants receiving different interventions) study of a single dose of 240 mg JNJ-56021927. The duration of study will be approximately of 78 days per participant. The study consists of 3 parts: Screening phase (that is, 21 days before study commences on Day 1); Open-label Treatment phase (consists of 4 parallel single-dose treatments); and End-of-Study (completion of the Hour 1344 PK sampling on Day 57, or upon early withdrawal). All the eligible participants will be randomly assigned to 1 of the 4 possible treatments: Treatment A (240 mg dose as softgel capsule); Treatment B (240 mg dose as Tablet Formulation 1); Treatment C (240 mg dose as Tablet Formulation 2); or Treatment D (240 mg dose as Tablet Formulation 3). Participants will fast overnight from food and fluids (excluding non-carbonated water) for at least 10 hours before study drug administration on Day 1. Blood samples will be collected pre-dose and over 1,344 hours (Day 57) after dosing for the determination of JNJ-56021927 concentration and its active metabolite. Relative bioavailability of 3 tablet formulations as compared to the softgel capsule formulation of JNJ-56021927 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

Single oral dose of JNJ-56021927 240 milligram (mg) softgel capsule on Day 1.

Group Type: ACTIVE_COMPARATOR

JNJ-56021927 Softgel Capsule

Intervention Type: DRUG

Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.

Treatment B

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 Tablet Formulation 1

Intervention Type: DRUG

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.

Treatment C

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 Tablet Formulation 2

Intervention Type: DRUG

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.

Treatment D

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.

Group Type: EXPERIMENTAL

JNJ-56021927 Tablet Formulation 3

Intervention Type: DRUG

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.

Interventions

JNJ-56021927 Softgel Capsule

Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.

Intervention Type: DRUG

JNJ-56021927 Tablet Formulation 1

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.

Intervention Type: DRUG

JNJ-56021927 Tablet Formulation 2

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.

Intervention Type: DRUG

JNJ-56021927 Tablet Formulation 3

Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.

Intervention Type: DRUG

Other Intervention Names

ARN-509

Eligibility Criteria

Inclusion Criteria

• Must agree to use an adequate contraception method as deemed appropriate by the investigator, always use a condom during sexual intercourse, and to not donate sperm during the study and for 3 months after receiving the study drug
• Body mass index between 18 and 30 kilogram (kg) per square meter, and body weight not less than 50 kg
• Blood pressure (supine for 5 minutes) between 90 and 140 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including pulse rate between 45 and 99 beats per minute (bpm), QT corrected Fridericia (QTcF) interval less than or equal to 450 milliseconds (msec), QRS interval of less than 120 msec, PR interval less than 220 msec, morphology consistent with healthy cardiac conduction and function
• Nonsmoker within the previous 2 months

Exclusion Criteria

• History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection
• Known hypersensitivity to Vitamin E
• History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
• Known allergy to the study drug or any of the excipients of the formulation
• Unable to swallow solid, oral dosage forms whole with the aid of water

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aragon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

56021927PCR1011

Identifier Type: OTHER

Identifier Source: secondary_id

CR104824

Identifier Type: -

Identifier Source: org_study_id