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This study will assess the absolute bioavailability of a single oral dose of lesinurad and evaluate the pharmacokinetic (PK) parameters of lesinurad and [14C]lesinurad in healthy adult male subjects.
In this study a single dose of lesinurad will be administered after an overnight fast followed by a single 15-minute infusion of a radiolabeled intravenous micro tracer dose of [14C]lesinurad to assess the in vivo performance of lesinurad.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesinurad and [14C]lesinurad | Experimental | Single oral dose of lesinurad and single infusion of [14C]lesinurad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesinurad 400 mg | Drug |
| ||
| [14C]lesinurad (100 μg per 10 mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of bioavailability in terms of lesinurad Pharmacokinetics (PK) profile from plasma. | PK profile in terms of maximum observed concentration (Cmax), time of occurrence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), apparent terminal half-life (t½), mean residence time (MRT), mean absorption time (MAT), and absolute bioavailability (F). | Day 1 to Day 5 |
| PK profile of [14C]lesinurad from plasma | PK profile in terms of Cmax, AUC, t½, MRT, total body clearance (CL), and volume of distribution at steady state (Vss). | Day 1 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Hall | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
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| Drug |
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