A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.

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Detailed Description

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This is a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Japanese Group 1: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 10 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Japanese Group 2: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 25 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Japanese Group 3: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 50 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Caucasian Group 1: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 10 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Caucasian Group 2: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 25 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Caucasian Group 3: JNJ-39439335/placebo (Part 1)

Group Type EXPERIMENTAL

JNJ-39439335 50 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Japanese Group 1: JNJ-39439335/placebo (Part 2)

Group Type EXPERIMENTAL

JNJ-39439335 10 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Japanese Group 2: JNJ-39439335/placebo (Part 2)

Group Type EXPERIMENTAL

JNJ-39439335 25 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Japanese Group 3: JNJ-39439335/placebo (Part 2)

Group Type EXPERIMENTAL

JNJ-39439335 50 mg

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

Placebo

Intervention Type DRUG

Multiple (once daily for 21 days) oral doses of matching placebo.

Interventions

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JNJ-39439335 10 mg

Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.

Intervention Type DRUG

JNJ-39439335 25 mg

Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.

Intervention Type DRUG

JNJ-39439335 50 mg

Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

Intervention Type DRUG

Placebo

Multiple (once daily for 21 days) oral doses of matching placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese or Caucasian participants
* Nonsmoker
* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
* Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
* Willing to adhere to the prohibitions and restrictions specified by the study protocol

Exclusion Criteria

* Oral temperatures \> 37.5 Celsius degrees
* Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
* Abnormal electrocardiogram (ECG) results
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
* History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes