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| ID | Type | Description | Link |
|---|---|---|---|
| 54135419TRD1016 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes in healthy male participants.
This is a single-center, open-label (identity of study drug will be known to participant and study staff), single-dose, parallel-group study. The study consist of Screening Phase (Days -21 to -2), Open-label treatment Phase (Day -1 up to Day 8) and End of Study (9 to 13 days after last study assessment). The total duration of study from the Screening Phase through Follow-up, is 37-41 days. Participants will be assigned to 1 of the two groups (Cohort 1 and Cohort 2) during the treatment phase. The participants will be primarily evaluated to determine the metabolic disposition of radiolabeled esketamine administered by the oral and intravenous routes. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 50 milligram (mg) of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration. |
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| Cohort 2 | Experimental | 20 mg of intravenous esketamine in 30 milliliter (mL), fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine 50 mg | Drug | 50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume) |
| Measure | Description | Time Frame |
|---|---|---|
| Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile) | Collection of urine and feces for 7 days is considered appropriate to characterize the metabolic profile of esketamine. Accelerator mass spectrometry (AMS), an ultrasensitive technique particularly suited for detection of low levels of 14C, will be used to assess levels of the microtracer in whole blood, plasma, and excreta (urine, feces). Plasma, urine and feces selected samples with relatively high radioactive content will be analyzed for metabolic profiling and identification using ultra performance liquid chromatography (UPLC) and AMS. | upto 168 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
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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 |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | United States |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| Esketamine 20 mg | Drug | 20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion. |
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| up to 41 days |