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| ID | Type | Description | Link |
|---|---|---|---|
| 42165279EDI1007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Dose Part | Experimental | Participants will receive a single oral dose of 25 mg JNJ-42165279 or placebo tablet under fasted condition in the morning on Day 1. |
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| Part 2: Multiple Dose Part | Experimental | After a washout period of at least 10 days, same participants from Part 1 will receive multiple daily dosing of 25 mg JNJ-42165279 or placebo tablet for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42165279 | Drug | 25 mg JNJ-42165279 tablet will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Screening up to Day 4 |
| Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Day -1 up to approximately 28 days |
| Part 1: Plasma Concentration of JNJ-42165279 | Plasma concentration of JNJ-42165279 will be reported. | Up to Day 4 |
| Part 2: Plasma Concentration of JNJ-42165279 | Plasma concentration of JNJ-42165279 will be reported. | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Minimum Observed Fatty Acid Amide Hydrolase (FAAH) Activity in White Blood Cells (WBC) Concentration (Rmin) | Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration). | Up to Day 4 |
| Part 2: Minimum Observed FAAH Activity in WBC Concentration (Rmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Cypress | California | 90630 | United States |
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| Placebo | Drug | Matching placebo tablet will be administered orally. |
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Rmin is the minimum observed FAAH activity in WBC concentration during a dosing interval (may or may not be the trough concentration). |
| Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) |
| Part 1: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin) | tmin is the time to the minimum observed FAAH activity in WBC concentration occurred during a dosing interval (may or may not be the trough concentration). | Up to Day 4 |
| Part 2: Time to Minimum Observed FAAH Activity in WBC Concentration (tmin) | tmin is the time to the minimum observed FAAH activity in WBC concentration occurred during a dosing interval (may or may not be the trough concentration). | Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) |
| Part 1: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma Fatty Acid Amides (FAA) | Maximum percent change in FAAH activity in WBCs, compared to baseline (that is, predose) value of Plasma FAA (ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA]) will be observed. | Baseline Up to Day 4 |
| Part 2: Maximum Percent Change in FAAH Activity in WBCs, Compared to Baseline (Predose) Value of Plasma FAA | Maximum percent change in FAAH activity in WBCs, compared to baseline (that is, predose) value of Plasma FAA (AEA, PEA, and OEA) will be observed. | Baseline, Day 1, Days 10 to 14 and Follow-up (approximately up to 28 days) |
| Part 1: Plasma Concentrations of Fatty Acid Amides (FAAs - N-Arachidonoyl ethanolamine [AEA], Palmitoylethanolamide/amine [PEA] and Oleoylethanolamide/amine [OEA]) | Plasma concentration of FAAs including AEA, PEA, and OEA will be reported. | Up to Day 3 |
| Part 2: Plasma Concentrations of FAAs (AEA, PEA and OEA) | Plasma concentration of FAAs including AEA, PEA, and OEA will be reported. | Day 1 and Days 10 to 14 |
| ID | Term |
|---|---|
| C000632387 | JNJ-42165279 |
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