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

What this Trial Is About

Researchers are evaluating the interaction between the drug ABP-671 and stable Allopurinol therapy in adults with gout. This open-label Phase 1 study aims to understand how ABP-671 affects Allopurinol's levels in the body, focusing on patients who have been on a consistent Allopurinol regimen. The study is sponsored by Atom Therapeutics Co., Ltd and focuses on drug-drug interactions in gout treatment. Participants will take part in three consecutive 7-day treatment periods: first with Allopurinol alone, then with both Allopurinol and ABP-671, and finally with ABP-671 alone. This design allows researchers to compare the pharmacokinetics of both drugs when given together and separately, assessing maximum plasma concentration and the area under the concentration-time curve. During the study, researchers will monitor blood samples at baseline and on several days up to day 21 to measure drug levels and interactions. Safety will be tracked by recording any treatment-emergent adverse events over an average period of 51 days. Participants will be involved in multiple visits for assessments throughout the study duration, which lasts approximately three weeks for treatment and follow-up.

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