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

NCT02160756 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-02-03

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Aragon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02160756 on ClinicalTrials.gov