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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with ABP-671 | Experimental | Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days. |
|
| Treatment with placebo | Placebo Comparator | Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 | Drug | ABP-671 is an investigational drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Measured by the number of patients with AEs | 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration of ABP-671 (Cmax) | 2 weeks | |
| Area under time-concentration curve (AUC) | 2 weeks | |
| Time of maximum observed plasma concentration of ABP-671 (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Armas, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| Placebo |
| Other |
Matching placebo |
|
| 2 weeks |
| Volume of distribution (Vd) | 2 weeks |
| Half life of ABP-671 (t1/2) | 2 weeks |
| The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid | 24 days |
| The effect of ABP-671 versus placebo on change in urine uric acid excretion | 24 days |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| 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 |