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This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single 1.0 mg dose of ABP-671 in the fasted state. |
|
| Treatment B | Experimental | Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 | Drug | ABP-671 Tablet 1.0 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma ABP-671 Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Uric Acid Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours |
| Serum Creatinine Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC, Inc. | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| 72 hours |
| Urine Uric Acid Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours |
| Urine Creatinine Concentration | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. | 72 hours |
| 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 |