Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
Atom Therapeutics Co., Ltd
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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.
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；
Location
- Wakefield Clinical ResearchCary, North Carolina