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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2013-09-06

No results posted yet for this study

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

Interventions

DRUG

single dose NJ-39758979/ matching placebo

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

DRUG

multi-dose JNJ-39758979 /matching placebo

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081821 on ClinicalTrials.gov