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

NCT ID: NCT01081821

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

001

single dose NJ-39758979/ matching placebo Single oral dose of JNJ-39758979 (either 50 100 300 600mg) or Placebo

Group Type: EXPERIMENTAL

single dose NJ-39758979/ matching placebo

Intervention Type: DRUG

Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo

002

multi-dose JNJ-39758979 /matching placebo JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo

Group Type: EXPERIMENTAL

multi-dose JNJ-39758979 /matching placebo

Intervention Type: DRUG

JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo

Interventions

single dose NJ-39758979/ matching placebo

Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo

Intervention Type: DRUG

multi-dose JNJ-39758979 /matching placebo

JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Cypress, California, United States

Countries

United States

Other Identifiers

CR016753

Identifier Type: -

Identifier Source: org_study_id