RecruitingPhase 1NCT07367971

Drug-Drug Interaction Study of ABP-671 in Gout Patients

Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients

Sponsor

Atom Therapeutics Co., Ltd

Enrollment

20 participants

Start Date

Jan 23, 2026

Study Type

INTERVENTIONAL

Conditions

Gout Gout Chronic DDI (Drug-Drug Interaction)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria3

Clinically significant hepatic impairment.
History of Allopurinol hypersensitivity.
Pregnancy or breastfeeding.

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Interventions

DRUGABP-671 plus allopurinol

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；