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| ID | Type | Description | Link |
|---|---|---|---|
| 42165279EDI1002 | Other Identifier | Janssen Research & Development, LLC | |
| 2013-002309-67 | EudraCT Number |
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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy, young and elderly, male and female participants after repeated oral dose administration.
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 (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) trial that will be conducted in two parts. Thirty two (32) healthy participants are planned to be included in total, in four cohorts (groups). Participants in each cohort will receive JNJ-42165279 (n=6) or placebo (n=2) once-daily for 10 consecutive days. In Part 1, two cohorts of healthy male participants, 18 to 55 years of age, will be enrolled. Cohort A will receive 50 mg JNJ-42165279 or placebo for 10 days, and Cohort B will receive 30 mg JNJ-42165279 or placebo for 10 days. In Part 2, Cohort C will consist of 8 healthy female participants of non-childbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. Cohort D will consist of 8 healthy elderly male or female participants, from 65 to 85 years of age, who will receive 100 mg JNJ-42165279 or placebo for 10 days. The dose may be adapted before each cohort starts based on available data. The maximum dose will not exceed 100 mg once-daily. For all participants, this study will consist of an eligibility screening examination (between 28 and 3 days prior to the first dose administration), a double-blind treatment phase consisting of 2 days before dosing, 10 dosing days (Day 1 to 10), 4 days after dosing (Day 11 to 14), and a follow-up examination (within 7 to 14 days after last dose administration). The total study duration for each participant will not exceed 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Part 1) | Experimental | Healthy male participants, 18 to 55 years of age. |
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| Cohort B (Part 1) | Experimental | Healthy male participants, 18 to 55 years of age. |
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| Cohort C (Part 2) | Experimental | Healthy female participants of nonchildbearing potential (surgically sterile or postmenopausal), 18 to 58 years of age. |
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| Cohort D (Part 2) | Experimental | Healthy elderly male or female participants, from 65 to 85 years of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-42165279 50 mg | Drug | JNJ-42165279 50 mg orally administered once daily for 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of JNJ-42165279 | 2 weeks | |
| Urine concentrations of JNJ-42165279 | 2 weeks | |
| Concentrations in cerebrospinal fluid of JNJ-42165279 | 2 weeks | |
| The number of participants with adserve events as a measure of safety and tolerability | Approximately 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Enzyme fatty acid amide hydrolase inhibition, as measured in white blood cells (WBCs) | Approximately 4 weeks | |
| Plasma concentrations of N-arachidonoylethanolamine (anandamide) | 2 weeks | |
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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 |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| ID | Term |
|---|---|
| C000632387 | JNJ-42165279 |
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| JNJ-42165279 100 mg | Drug | JNJ-42165279 100 mg orally administered once daily for 10 days. |
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| JNJ-42165279 30 mg | Drug | JNJ-42165279 30 mg orally administered once daily for 10 days. |
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| Placebo | Drug | Matching placebo orally administered once daily for 10 days. |
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| Plasma concentrations of palmitoylethanolamide |
| 2 weeks |
| Plasma concentrations of oleoylethanolamide | 2 weeks |
| Serum concentrations of prolactin | 10 days |
| Saliva concentrations of cortisol | 10 days |
| Concentrations in cerebrospinal fluid of N-arachidonoylethanolamine (anandamide) or its metabolites | 9 days |
| Concentrations in cerebrospinal fluid of palmitoylethanolamide or its metabolites | 9 days |
| Concentrations in cerebrospinal fluid of oleoylethanolamide or its metabolites | 9 days |