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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:July 2012
End Date:March 2013
Email:JNJ.CT@sylogent.com

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A Double-Blind, Randomized, Placebo-Controlled, Sequential Group, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Subjects


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.


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.

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
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