NCT03649997

A Study of Single and Multiple Ascending Doses of JNJ-61393215 in Healthy Participants

A Multi-cohort, Randomized Study in Healthy Subjects to Assess the Pharmacokinetics and Safety of Single and Multiple Ascending Doses of JNJ-61393215 (Suspension), and to Assess the Relative Bioavailability, and the Effect of Food on the Pharmacokinetics, of a New Solid Formulation (Capsules) of JNJ-61393215

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this 3 part study are; Part 1: to investigate the pharmacokinetic (PK), safety and tolerability of JNJ-61393215 suspension (ascending dose levels) after single oral dose administration under fasted conditions, Part 2: to evaluate the relative bioavailability of a solid JNJ-61393215 capsule formulation compared to a suspension of JNJ-61393215 under fasted conditions, and the effect of food on the PK of the solid JNJ-61393215 capsule formulation, Part 3: to investigate the PK, safety, and tolerability of JNJ-61393215 suspension (ascending dose levels) after 7 days of once daily dosing in under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-61393215	Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.
DRUG	Placebo	Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.
DRUG	JNJ-61393215	Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.

Timeline

• Start date: 2018-08-28
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2018-08-28
• Last updated: 2025-04-27

Locations

1 site across 1 country: Netherlands