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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004119-38 | EudraCT Number |
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This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of [14C]-E6007 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-E6007 | Experimental | Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-E6007 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of E6007 derived from whole blood | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose | |
| Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007 | Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose | |
| Total radioactivity derived from whole blood | Up to 11 days | |
| Total radioactivity in urine | Up to 11 days | |
| Total radioactivity in feces | Up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any serious adverse event | Up to 11 days | |
| Number of participants with any non-serious adverse event | Up to 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Ltd. | Leeds | West Yorkshire | United Kingdom |
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