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The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.
Primary Objectives:
• To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy Volunteers (HVs).
Secondary Objectives:
• To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single ascending oral doses of ABP-671 in HVs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP-671, Cohort 1- | Experimental | ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo). |
|
| ABP-671, Cohort 2- | Experimental | ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo). |
|
| ABP-671, Cohort 3- | Experimental | ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo). |
|
| ABP-671, Cohort 4- | Experimental | ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 | Drug | Drug: ABP-671, single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events | baseline to 7 days |
| Maximum tolerable dose | Maximum tolerable dose | baseline to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration | Peak plasma concentration | baseline to 72 hours |
| half-life | half-life | baseline to 72 hours |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Danielle Armas, M.D. | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| Placebo | Other | Other: Placebo, single oral dose |
|
| area under the curve | area under the curve | baseline to 72 hours |
| volume of distribution | volume of distribution | baseline to 72 hours |
| level of serum and urine uric acid | level of serum and urine uric acid | baseline to 72 hours |
| level of serum and urine creatinine | level of serum and urine creatinine | baseline to 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |