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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT01081821
Run by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
People needed: 61
Starts: 2010-02-01
Expected to finish: 2010-12-01
Last updated by the study team: 2013-09-06

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Cypress, California, United States

Full record on ClinicalTrials.gov

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