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This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat | Experimental | Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: RDEA3170 10 mg or placebo qd. |
|
| RDEA3170 | Experimental | Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: febuxostat 40 mg qd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA3170 10 mg | Drug | RDEA3170 10 mg once daily (qd) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of RDEA3170 from plasma and urine and febuxostat from plasma | Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance | Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only) |
| Measure | Description | Time Frame |
|---|---|---|
| PD profile of RDEA3170 and febuxostat alone and in combination | Profile from serum and urine in terms of sUA concentration, renal clearance of uric acid, urine uric acid excretion amounts, and fractional excretion of uric acid. sUA: serum urate | Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only) |
| Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters |
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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 |
|---|---|---|---|---|---|---|
| Kalamazoo | Michigan | 49007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32951150 | Derived | Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19. |
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| ID | Term |
|---|---|
| C000628929 | verinurad |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Febuxostat 40 mg |
| Drug |
Febuxostat 40 mg qd |
|
| placebo | Drug | placebo qd |
|
| 8 weeks |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |