NCT02555124

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants

A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral administration.

Detailed description

This is a single center, double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment \[with no drug in it\] that is compared in a clinical trial with a drug to test if the drug has a real effect), randomized (study medication assigned to participants by chance), single-ascending dose study. The study consists of a screening phase, an in-clinic treatment phase, and a follow-up phase. The study duration for each subject will be approximately 5 weeks from screening (Day -28 to Day -3), in-clinic period (Day -2 to Day 4) to follow up visit (Day 8). Participants will receive a single oral dose of JNJ-42847922 or placebo in 3 cohorts. Participants' safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-42847922, 5 mg	Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.
DRUG	JNJ-42847922, 20 mg	Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.
DRUG	JNJ-42847922, 40 mg	Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.
DRUG	Placebo	Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.

Timeline

• Start date: 2015-09-12
• Primary completion: 2015-10-31
• Completion: 2015-10-31
• First posted: 2015-09-21
• Last updated: 2017-03-10

Locations

1 site across 1 country: Japan