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This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.
In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesinurad and Tums | Experimental | Day 1: 240 mL water or 240 mL water and Tums Day 2: Lesinurad 400 mg or Lesinurad 400 mg and Tums; Day 6: 240 mL water and Tums or 240 mL water; Day 7: Lesinurad 400 mg and Tums or Lesinurad 400 mg |
|
| Lesinurad and MINTOX | Experimental | Day 1: 240 mL water or 240 mL water and MINTOX ; Day 2: Lesinurad 400 mg or Lesinurad 400 mg and MINTOX; Day 6: 240 mL water and MINTOX or 240 mL water; Day 7: Lesinurad 400 mg and MINTOX or Lesinurad 400 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesinurad 400 mg | Drug |
| ||
| Tums 500 mg and 750 mg |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of lesinurad from plasma and urine | Plasma 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), renal clearance (CLR), and adverse event (Ae). | Day 2 and Day 7 |
| PD profile of Lesinurad from serum and urine | Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid. | Day 2 and Day 7 |
| 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 |
|---|---|---|---|---|---|---|
| Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
| D002119 | Calcium Carbonate |
| C008570 | aluminum hydroxide, magnesium hydroxide, simethicone drug combination |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Drug |
|
| MINTOX 10 mL | Drug |
|
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |