A Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 in Healthy Male Participants

NCT ID: NCT02031666

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-04-30

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability (the extent to which a medication or other substance becomes available to the body) of JNJ-56021927 when administered as 7 test tablet formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927 in healthy male participants under fasted conditions at a single dose of 240 mg.

Detailed Description

This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), single-center, 8-treatment, parallel-group (each group of participants will be treated at the same time) study. Approximately 120 participants (15 participants in each treatment group) will participate in this study. All participants will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G, and H). The study will consist of a screening phase (within 21 days before the first administration of the study medication), a treatment phase with 8 parallel single-dose treatments (8 days); a follow up phase (42 days) and an end-of-study or early withdrawal assessments (Day 57). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored throughout the study. The duration of participation in the study for an individual participant will be approximately 78 days.

Conditions

Healthy

Study Design

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

Study Groups

Treatment A

15 participants will receive 240-mg dose as Softgel Capsule Formulation of JNJ-56021927.

Group Type: ACTIVE_COMPARATOR

JNJ-56021927 capsule

Intervention Type: DRUG

Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment B

15 participants will receive 240-mg dose as Tablet Formulation number 1 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment C

15 participants will receive 240-mg dose as Tablet Formulation number 2 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment D

15 participants will receive 240-mg dose as Tablet Formulation number 3 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment E

15 participants will receive 240-mg dose as Tablet Formulation number 4 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment F

15 participants will receive 240-mg dose as Tablet Formulation number 5 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment G

15 participants will receive 240-mg dose as Tablet Formulation number 6 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Treatment H

15 participants will receive 240-mg dose as Tablet Formulation number 7 of JNJ-56021927.

Group Type: EXPERIMENTAL

JNJ-56021927 tablet

Intervention Type: DRUG

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Interventions

JNJ-56021927 capsule

Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.

Intervention Type: DRUG

JNJ-56021927 tablet

Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.

Intervention Type: DRUG

Other Intervention Names

ARN-509

Eligibility Criteria

Inclusion Criteria

• During the study and for 3 months after receiving study medication, must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception), always use a condom during sexual intercourse and to not donate sperm
• Body mass index (weight [kg]/height [m]2) between 18 and 30 kg/m2 and body weight not less than 50 kg
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
• A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
• Non-smoker for 2 months prior to study participation

Exclusion Criteria

• History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, and infection
• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis, physical examination, vital signs or 12-lead ECG at screening or at admission to the study center as deemed appropriate by the investigator
• Presence of sexual dysfunction (eg, abnormal libido or erectile dysfunction) or any medical condition that would affect sexual function
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen within 14 days before the first dose of the study drug is scheduled
• History of clinically significant allergies or known hypersensitivity to vitamin E

• 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

Locations

Tempe, Arizona, United States

Countries

United States

Other Identifiers

56021927PCR1007

Identifier Type: OTHER

Identifier Source: secondary_id

CR103299

Identifier Type: -

Identifier Source: org_study_id