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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: multi-dose JNJ-39758979 /matching placebo

Drug: single dose NJ-39758979/ matching placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01081821

CR016753

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Must be generally in good health
If japanese, must have lived outside of Japan for no more than 5 years and whose parents and grandparents are Japanese
Have negative result for HIV, hepatitis B, and hepatitis C
Must be willing to use an acceptable method of birth control for 6 months after the last dose and to not donate sperm during the study and for 6 months after the last dose
Must have a negative test for alcohol and drugs of abuse at check-in

Exclusion criteria

History of alcohol or drug abuse within the last 5 years (consuming more than 14 drinks per week)
Average consumption of more than 3 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
Use of vitamins, herbal supplements, energy drinks or St.John's Wort (hypericin) for 14 days before first dosing
Receipt of an experimental drug or medical device within the last month