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A randomized, double-blind, placebo-controlled, dose-escalation study will be conducted in healthy volunteers. This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ABP-745 following single (Part 1) and multiple (Part 2) oral doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| ABP-745 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-745 | Drug | 0.5, 5 or 25 mg tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (Safety and Tolerability) | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic parameters including peak plasma concentration (Cmax) | Up to Day 11 | |
| Urine pharmacokinetic parameters including amount excreted in urine over the sampling interval (Ae) | Up to Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Drug |
Placebo tablet |
|
| 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 |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |