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| ID | Type | Description | Link |
|---|---|---|---|
| 26489112MDD1001 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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The purpose of this study is to evaluate the absorption, the metabolic pathways (a series of metabolic reactions) and the excretion of JNJ26489112 in healthy male adult participants after administration of a single oral dose of 1000 mg of 14C-JNJ26489112.
This is a single-dose, 1-arm (group), open-label study (all people know the identity of the intervention) in healthy adult male participants. On Day 1, after completing a 10-hour overnight fast, participants will receive a single oral dose of 14C-JNJ-26489112 1,000 mg as a 10-mL suspension. Participants will be recruited in 2 cohorts. The 6 participants in the first cohort were dosed in error with doses less than 1000 mg. So, an additional cohort of 4 participants will be enrolled to receive a single oral dose of 1000 mg 14C-JNJ 26489112. Total 10 participants will receive the study medication. Safety will be assessed by monitoring vital signs, physical examinations, electrocardiograms, and clinical laboratory tests throughout the study. The total duration of the study for each participant will be approximately 5 weeks (including up to 3 weeks for screening and 11 to 15 days of study) or up to 1 additional week for participants who excrete 14C-JNJ26489112 more slowly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-JNJ26489112 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-JNJ26489112 | Drug | Participants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of 14C-JNJ-26489112 in plasma | 240 hours | |
| Mass balance after an oral dose of 14C-JNJ-26489112 as generated from recovery of total radioactivity excreted in urine and feces | 240 hours | |
| Routes of 14C-JNJ-26489112 elimination measured through total radioactivity concentrations in urine and feces | 240 hours | |
| Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivity levels in blood | 240 hours | |
| Identification of major metabolites in plasma, urine, and feces | 240 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to Day 15 | |
| Number of participants with a suicide-related outcome | Suicide related outcome measures will be assessed by using Columbia-Suicide Severity Rating Scale (C-SSRS). By using the C-SSRS, potential suicide-related events will be categorized using the codes defined by the Columbia Classification Algorithm of Suicide Assessment from Code 0: no event that can be assessed based on the C-SSRS to Code 9: not enough information, nonfatal. The 4 suicide-related outcomes of interest are the following: suicidal ideation (Code 4), suicidal behavior (Codes 1 to 3), suicidal behavior or ideation (Codes 1 to 4), and possible suicidal behavior or ideation (Codes 1 to 6 and 9). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| Screening (Days -21 to -1), Day 2 and end-of-study (Day 15) |