NCT01081821

Single and Multiple Dose Study to Explore the Safety and Pharmacokinetics of JNJ-39758979 In Healthy Male Volunteers of Either Caucasian or Japanese Descent

A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Investigate the Safety and Pharmacokinetics of JNJ-39758979 in Healthy Japanese and Caucasian Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single doses of JNJ-39758979 in healthy Japanese volunteers and multiple doses of JNJ-39758979 in healthy Japanese and Caucasian volunteers.

Detailed description

This study will assess the safety and pharmacokinetics of JNJ-39758979 or placebo (which looks like the drug being studied but has no active ingredients) in healthy volunteers. This study is being conducted in two parts. Part 1 is a randomized (study drug will be assigned by chance), double-blind (neither the physician nor volunteer knows the identity of the assigned drug) study evaluating the safety, tolerability and pharmacokinetics of single doses of JNJ-39758979 and placebo in 36 healthy Japanese male volunteers. Part 2 is a randomized, double-blind study evaluating the safety, tolerability, and pharmacokinetics of multiple doses of JNJ-39758979 and placebo in 24 healthy Japanese males and 24 healthy Caucasian males. For Part 1, the participation period is a maximum of 56 days, including a screening visit, a 7-day in-clinic period and two follow-up visits. For Part 2, the participation period is a maximum of 202 days, including a screening visit, a 17-day in-clinic period and two follow-up visits. For both parts of the study, safety evaluations, which will include ECG (a cardiac function test), vital signs and monitoring of side-effects will be performed. Additionally, blood and urine samples will be collected for evaluation. Part 1: volunteers will receive a single oral (by mouth) dose of JNJ-39758979 (50, 100, 300, or 600mg) or placebo; Part 2: volunteers will receive an oral dose of JNJ-39758979 (300 mg) or placebo once a day for 14 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	single dose NJ-39758979/ matching placebo	Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo
DRUG	multi-dose JNJ-39758979 /matching placebo	JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-03-05
• Last updated: 2013-09-06

Locations

1 site across 1 country: United States