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This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABP-671 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABP-671 plus allopurinol | Drug | All subjects undergo three sequential 7-day periods: Period 1 (Day 1-7): Allopurinolï¼› Period 2 (Day 1-7): Allopurinol Plus ABP-671ï¼› Period 3 (Day 1-7): ABP-671ï¼› |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of allopurinol | Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state. | Base line, through Day1, Day 7,Day8,D14,D15,D21 |
| Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol | Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state. | Base line, through Day1, Day 7,Day8,D14,D15,D21 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of ABP-671 | Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period. | Though Day7,Day8,Day14,Day15,Day21 |
| Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MaoE Sun | Contact | 13914017855 | mao.e.sun@atombp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wakefield Clinical Research | Recruiting | Cary | North Carolina | 27560 | United States |
there is no need at present.
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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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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period. |
| Though Day7,Day8,Day14,Day15,Day21 |
| Incidence of treatment-emergent adverse events (TEAEs) | Number and percentage of participants experiencing treatment-emergent adverse events. | Through study completion, an average of 51 days |
| 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 |