NCT02945007

A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formulation Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of Oral Concept Formulation

A Phase 1, Open-label, Randomized Crossover Study, in Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single 500-mg Dose of JNJ-53718678 Administered as (an) Oral Concept Formulation(s) Compared to the Current Oral Solution and to Assess the Effect of Food on the Pharmacokinetics of (an) Oral Concept Formulation(s)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the relative bioavailability of 1 to 3 concept formulations of JNJ-53718678 compared to the currently existing oral solution, and to assess the effect of food on the bioavailability of 1 to 3 oral concept formulations of JNJ-53718678 when administered as a single oral dose of 500 milligram (mg) in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-53718678	Participants will receive JNJ-53718678 under fed or fasted conditions.

Timeline

• Start date: 2016-11-08
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2016-10-26
• Last updated: 2020-03-10

Locations

1 site across 1 country: Belgium