Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 39439335PAI1005 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese Group 1: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Japanese Group 2: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Japanese Group 3: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Caucasian Group 1: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Caucasian Group 2: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Caucasian Group 3: JNJ-39439335/placebo (Part 1) | Experimental |
| |
| Japanese Group 1: JNJ-39439335/placebo (Part 2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-39439335 10 mg | Drug | Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (Part 1) | Approximately 8 weeks | |
| Incidence of Adverse Events (Part 2) | Approximately 11 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Japanese Group 2: JNJ-39439335/placebo (Part 2) | Experimental |
|
| Japanese Group 3: JNJ-39439335/placebo (Part 2) | Experimental |
|
| JNJ-39439335 25 mg | Drug | Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. |
|
| JNJ-39439335 50 mg | Drug | Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. |
|
| Placebo | Drug | Multiple (once daily for 21 days) oral doses of matching placebo. |
|