NCT02398591

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants

A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of three dosages (250, 500, and 1000 milligram \[mg\], or maximum tolerated dose \[MTD\]) of JNJ 53718678 when administered as single dose in fasting conditions in healthy Japanese adult participants in 3 cohorts.

Detailed description

This is a Phase 1, single center, double-blind (study in which neither the researchers nor the participants know what treatment the participants are receiving), placebo-controlled (study in which the experimental treatment or procedure is compared to placebo treatment), randomized (study medication assigned to participants by chance) study in healthy Japanese adult participants residing outside of Japan. The study will consist of a Screening phase, an In-clinic treatment phase, and a follow-up phase. The study duration for each participant will be approximately 6 weeks from Screening (Day -28 to Day -2) to follow up visit (Day 10 to 14). Participants will be randomly assign to receive JNJ 53718678 or placebo, at planned dose of 250, 500 and 1000 milligram (mg). Planned doses will be stepwise escalated, if the safety and tolerability of the preceding dose(s) are found to be acceptable, and the maximum tolerated dose (MTD) is not reached. De-escalation may be performed in order to study an intermediate dose. The safety, tolerability and pharmacokinetic (PK) profile of JNJ-53718678 will primarily be evaluated. Participants' safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ 53718678	JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
DRUG	Placebo	Placebo matching to JNJ 53718678 will be orally administered once on Day 1.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-15
• Completion: 2015-07-15
• First posted: 2015-03-25
• Last updated: 2017-07-11

Locations

1 site across 1 country: United Kingdom