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This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of [14 C]RDEA3170 in healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDEA3170 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA3170 10 mg | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of AME in terms of pharmacokinetics (PK), metabolism, and excretion | PK profile in terms of AUC, Tmax, Cmax, t1/2, Ae, CLr, and CL/F. AUC: area under the concentration-time curve; Tmax: time to reach maximum concentration; Cmax: maximum concentration; t1/2: apparent terminal half-life; Ae: amount of compound excreted in urine unchanged; CLr: renal clearance; CL/F: total body clearance corrected for bioavailability Metabolic profile of RDEA3170 in plasma, urine, and feces. Excretion in terms of recovery of radioactivity in urine and feces. | Day 1 predose, 15, 30, 45 mins, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36, 48, 54, 60, 72 hrs postdose (blood and plasma only); Day 1, -12 to 0, 0-6, 6-12, 12-24 hrs postdose (urine and feces only) |
| 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 |
|---|---|---|
| S. Baumgartner | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000628929 | verinurad |
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