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This is an open-label, single dose study in healthy male subjects.
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2609 | Experimental | Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2609 | Drug | Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Elimination of E2609: urine/feces concentration | Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose. | Predose and every 24 hours postdose up to 28 days |
| Pharmacokinetics: Plasma concentration of E2609/metabolite | Total radioactivity will be analyzed in whole blood, plasma, and red blood cells. | Predose andup to 648 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration | Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods. A scintillation counter and/or AMS will be used to detect radioactivity. If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses. |
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Inclusion Criteria
Subjects must meet criteria to be included in this study, including but not limited to the following:
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
Restrictions will apply on prior and concomitant medications, food and beverages
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States | ||
| Covance Laboratories |
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| Predose andup to 648 hours postdose |
| Madison |
| Wisconsin |
| 53704 |
| United States |