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This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | VBR 300 mg solution containing 2 µCi [14C]VBR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebicorvir (VBR) | Drug | 300mg Vebicovir containing 2 µCi [14C]VBR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Urine up to the Last Sampling Interval (Ae-urine, 14C) | Before dosing and at prespecified time intervals up to 168 hours after dosing | |
| Mass Balance: Cumulative Amount of [14C] Radiolabel Excreted in Feces up to the Last Sampling Interval (Ae-feces, 14C) | Before dosing and at prespecified time intervals up to 168 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Adverse Events | Up to 168 hours | |
| Number of Participants Discontinued from the Study Due to an Adverse Event | Up to 168 hours |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |