NCT03023852

A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants

A Phase 1, Open-label, Randomized, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the rate and extent of absorption of JNJ63623872 following administration of a single oral dose of 2\*300 milligram (mg) given as 2 concept single agent tablet formulations compared to the administration of 2\*300 mg JNJ63623872 reference tablets, under fasted conditions in healthy adult participants and to assess the rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a single oral dose of 2\*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose combination (FDC) tablet formulation compared to the coadministration of 2\*300 mg JNJ63623872 tablets (reference formulation) and 1\*75 mg oseltamivir capsule, under fasted conditions in healthy adult participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-63623872	Participants will receive JNJ-63623872 600 mg (2\*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
DRUG	Oseltamivir	Participants will receive Oseltamivir 75 mg (1\*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.

Timeline

• Start date: 2017-02-14
• Primary completion: 2017-04-14
• Completion: 2017-04-14
• First posted: 2017-01-18
• Last updated: 2017-05-25

Locations

1 site across 1 country: Belgium