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The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose | Experimental | Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. |
|
| Multiple Dose | Experimental | RDEA3170 12 mg once daily (qd) |
|
| Single Dose Food Effect | Experimental | Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA3170 4.5 mg | Drug |
| ||
| RDEA3170 6 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Cmax | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Cmax | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Time of Occurrence of maximum observed concentration (Tmax) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Area under the plasma concentration time curve (AUC) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Tmax | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| AUC | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Tmax | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events in terms of changes in laboratory parameters | 6 weeks | |
| Incidence of Adverse Events in terms of electrocardiogram parameters | 6 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Hall, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 7, 2017 | |
| Reset | Jun 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 7, 2017 | Jun 12, 2018 |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000628929 | verinurad |
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|
| RDEA3170 12 mg | Drug |
|
| Days -1, 1, 7 and 8 |
| AUC | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Serum urate concentration | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Urine uric acid excretion amount | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Renal clearance of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Fractional excretion of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 |
| Serum urate concentration | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Urine uric acid excretion amount | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Renal clearance of uric acid | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Fractional excretion of uric acid | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 |
| Serum urate concentration | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Urine uric acid excretion amount | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Renal Clearance of Uric Acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Fractional excretion of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| Incidence of Adverse Events in terms of vital signs |
| 6 weeks |
| Incidence of Adverse Events in terms of physical examination findings | 6 weeks |
| Apparent terminal half-life (t1/2) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine | Days -1, 1, 5 and 9 |
| t1/2 | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 |
| t1/2 | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine | Days -1, 1 and 7 |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |