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This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-EP262 25 mg | Experimental | Administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EP262 | Drug | Single dose of [14C]-EP262 administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance of [14C]-EP262 | Assessed by the total recovery of radioactivity from urine and feces | Measured from Day 1 to End of Study or Early Termination (Approximately 1 month) |
| Pharmacokinetics (PK) of EP262 and [14C] | Assessed by the concentration of EP262 in plasma and [14C] in whole blood, plasma, urine, and feces | Measured from Day 1 to End of Study or Early Termination (Approximately 1 month) |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite profile of EP262 | Assessed by the concentration of EP262 metabolites in plasma, urine, and feces | Measured from Day 1 to End of Study or Early Termination (Approximately 1 month) |
| Safety and tolerability of [14C]-EP262 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron Clinical Pharmacology Center (CPC) | Baltimore | Maryland | 21201 | United States |
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Assessed by the incidence of treatment emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, and physical examination findings
| Measured from Day 1 to End of Study or Early Termination (Approximately 1 month) |