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

NCT01081821 | Completed Phase 1

• 1 other identifier: CR016753
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

JNJ 39758979; Japanese descent

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic and safety profile of single dose and multi-dose JNJ-39758979 as determined by lab and other safety evaluations

  Through day 35 (after treatment) in Part 1 and through day 182 (after treatment) in Part 2

Study Arms (2)

001

EXPERIMENTAL

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

Drug: single dose NJ-39758979/ matching placebo

002

EXPERIMENTAL

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

Drug: multi-dose JNJ-39758979 /matching placebo

Interventions

single dose NJ-39758979/ matching placebo DRUG

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

001

multi-dose JNJ-39758979 /matching placebo DRUG

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

002

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

US (1)