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

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.

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