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Study to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076 in Healthy Participants

NCT02951845 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of the study is to assess the oral bioavailability of the two tablet formulations of JNJ-54416076 relative to the suspension formulation and to investigate the effect of a high fat meal on the pharmacokinetics of the tablet formulation in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

JNJ-54416076 (Oral Suspension)

Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.

DRUG

JNJ-54416076 (Formulation 1: Direct Compression Tablets)

Participants will receive JNJ-54416076 Tablet formulation 1 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 1.

DRUG

JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)

Participants will receive JNJ-54416076 Tablet formulation 2 (5\*5 mg Tablets \[25 mg total\]) under fasted and fed condition in Part 2.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-11-22
Primary Completion
2017-02-17
Completion
2017-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02951845 on ClinicalTrials.gov