A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants
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ClinicalTrials.gov Identifier: NCT01631487 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Last Update Posted : June 25, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: JNJ-39439335 10 mg Drug: JNJ-39439335 25 mg Drug: JNJ-39439335 50 mg Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Caucasian Group 1: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Caucasian Group 2: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Caucasian Group 3: JNJ-39439335/placebo (Part 1) |
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Japanese Group 1: JNJ-39439335/placebo (Part 2) |
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Japanese Group 2: JNJ-39439335/placebo (Part 2) |
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
Experimental: Japanese Group 3: JNJ-39439335/placebo (Part 2) |
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. Drug: Placebo Multiple (once daily for 21 days) oral doses of matching placebo. |
- Plasma concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 14 days ]
- Urine concentrations of JNJ-39439335 (Part 1) [ Time Frame: up to 5 days ]
- Plasma concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ]
- Urine concentrations of JNJ-39439335 (Part 2) [ Time Frame: up to 21 days ]
- Incidence of Adverse Events (Part 1) [ Time Frame: Approximately 8 weeks ]
- Incidence of Adverse Events (Part 2) [ Time Frame: Approximately 11 weeks ]

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Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631487
United States, California | |
Cypress, California, United States |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01631487 |
Other Study ID Numbers: |
CR100890 39439335PAI1005 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | June 25, 2013 |
Last Verified: | June 2013 |
Healthy JNJ-39439335 Japanese Caucasian Male |