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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-39439335 10 mg
* Drug: JNJ-39439335 25 mg
* Drug: JNJ-39439335 50 mg
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 10 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 25 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 50 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Caucasian Group 1: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 10 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Caucasian Group 2: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 25 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Caucasian Group 3: JNJ-39439335/placebo (Part 1)<br> | Drug: JNJ-39439335 50 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 2)<br> | Drug: JNJ-39439335 10 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 2)<br> | Drug: JNJ-39439335 25 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|
| Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 2)<br> | Drug: JNJ-39439335 50 mg<br>* Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.<br>Drug: Placebo<br>* Multiple (once daily for 21 days) oral doses of matching placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of JNJ-39439335 (Part 1) |  | up to 14 days | 
| Urine concentrations of JNJ-39439335 (Part 1) |  | up to 5 days | 
| Plasma concentrations of JNJ-39439335 (Part 2) |  | up to 21 days | 
| Urine concentrations of JNJ-39439335 (Part 2) |  | up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (Part 1) |  | Approximately 8 weeks | 
| Incidence of Adverse Events (Part 2) |  | Approximately 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, JNJ-39439335, Japanese, Caucasian, Male