NCT02951845

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

An Exploratory Open-Label, Single Dose, Randomized, Three-Way Crossover Study In Healthy Subjects to Investigate the Food Effect and Oral Bioavailability of Tablet Formulations Relative to Suspension Formulation of JNJ-54416076

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2016-11-22
• Primary completion: 2017-02-17
• Completion: 2017-02-17
• First posted: 2016-11-01
• Last updated: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study