Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
| Registry | NCT07367971 |
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| Status | Recruiting |
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| Phase | Phase 1 |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 20 (Estimated) |
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| Sponsor | Atom Therapeutics Co., Ltd (Industry) |
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| Conditions | Gout Chronic, Gout, DDI (Drug-Drug Interaction) |
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| Interventions | ABP-671 plus allopurinol (Drug) |
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| Dates | start 2026-01-23, primary completion 2026-07-31 (estimated), completion 2026-08-31 (estimated), first posted 2026-01-26, last updated 2026-04-14 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Gout Chronic All trials for Gout All trials of ABP-671 plus allopurinol
-Summary
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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| ABP-671 | Experimental | Drug: ABP-671 plus allopurinol | |
- ABP-671 plus allopurinol (Drug): All subjects undergo three sequential 7-day periods:
Period 1 (Day 1-7): Allopurinol；
Period 2 (Day 1-7): Allopurinol Plus ABP-671；
Period 3 (Day 1-7): ABP-671；
+Outcome measures
Primary outcomes
- Maximum plasma concentration (Cmax) of allopurinol [Base line, through Day1, Day 7,Day8,D14,D15,D21]: Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
- Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol [Base line, through Day1, Day 7,Day8,D14,D15,D21]: 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.
Secondary outcomes
- Maximum plasma concentration (Cmax) of ABP-671 [Though Day7,Day8,Day14,Day15,Day21]: Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
- Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 [Though Day7,Day8,Day14,Day15,Day21]: 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.
- Incidence of treatment-emergent adverse events (TEAEs) [Through study completion, an average of 51 days]: Number and percentage of participants experiencing treatment-emergent adverse events.
+Eligibility
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria:
* Adults 18-75 years with clinical diagnosis of gout.
* Stable Allopurinol therapy QD for ≥14 days prior to Day 1.
* Cohort N: Normal renal function.
* Cohort R: Moderate renal impairment.
Exclusion Criteria:
* Clinically significant hepatic impairment.
* History of Allopurinol hypersensitivity.
* Pregnancy or breastfeeding.
+Locations (1)
| Facility | City | Country | Status |
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| Wakefield Clinical Research | Cary, North Carolina | United States | Recruiting |