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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01081821
First received: March 4, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: single dose NJ-39758979/ matching placebo
Drug: multi-dose JNJ-39758979 /matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized, Single Ascending and Multiple Dose Study to Investigate the Safety and Pharmacokinetics of JNJ-39758979 in Healthy Japanese and Caucasian Adult Male Subjects

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Pharmacokinetic and safety profile of single dose and multi-dose JNJ-39758979 as determined by lab and other safety evaluations [ Time Frame: Through day 35 (after treatment) in Part 1 and through day 182 (after treatment) in Part 2 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: February 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
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
Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo
Experimental: 002
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
JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081821

Locations
United States, California
Cypress, California, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01081821     History of Changes
Other Study ID Numbers: CR016753
Study First Received: March 4, 2010
Last Updated: September 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
JNJ 39758979
Japanese descent

ClinicalTrials.gov processed this record on July 22, 2014