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

NCT07367971 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ABP-671-DDI-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

gout; Gout Chronic; ABP-671

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of allopurinol

  Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.

  Base line, through Day1, Day 7,Day8,D14,D15,D21

• Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol

  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.

  Base line, through Day1, Day 7,Day8,D14,D15,D21

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax) of ABP-671

  Though Day7,Day8,Day14,Day15,Day21

• Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671

  Though Day7,Day8,Day14,Day15,Day21

• Incidence of treatment-emergent adverse events (TEAEs)

  Through study completion, an average of 51 days

Study Arms (1)

ABP-671

EXPERIMENTAL

Drug: ABP-671 plus allopurinol

Interventions

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；

ABP-671

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (1)

Wakefield Clinical Research

Cary, North Carolina, 27560, United States

RECRUITING

MeSH Terms

Conditions

Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

MaoE Sun

CONTACT

13914017855; mao.e.sun@atombp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 26, 2026
• Study Start: January 23, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)