NCT02160756

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

A Single-Dose, Open-Label, Randomized, Parallel-Group Study to Assess the Relative Bioavailability of 3 Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 Under Fasted Conditions in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Aragon Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	JNJ-56021927 Softgel Capsule	Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.
DRUG	JNJ-56021927 Tablet Formulation 1	Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
DRUG	JNJ-56021927 Tablet Formulation 2	Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
DRUG	JNJ-56021927 Tablet Formulation 3	Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-06-11
• Last updated: 2025-02-03