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

Atom Therapeutics Co., Ltd

Status and phase: Not yet enrolling; Phase 1

Conditions: Gout Chronic; DDI (Drug-Drug Interaction); Gout

Treatments: Drug: ABP-671 plus allopurinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT07367971

ABP-671-DDI-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

ABP-671

Experimental group

Treatment:

Drug: ABP-671 plus allopurinol