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

April 12, 2026 updated by: Atom Therapeutics Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Cary, North Carolina, United States, 27560
        • Recruiting
        • Wakefield Clinical Research
        • Principal Investigator:
          • Xiaohuan Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABP-671
Drug: ABP-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；

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of allopurinol
Time Frame: Base line, through Day1, Day 7,Day8,D14,D15,D21
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
Time Frame: Base line, through Day1, Day 7,Day8,D14,D15,D21
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax) of ABP-671
Time Frame: Though Day7,Day8,Day14,Day15,Day21
Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Though Day7,Day8,Day14,Day15,Day21
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671
Time Frame: Though Day7,Day8,Day14,Day15,Day21
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Though Day7,Day8,Day14,Day15,Day21
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Through study completion, an average of 51 days
Number and percentage of participants experiencing treatment-emergent adverse events.
Through study completion, an average of 51 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atom Therapeutics Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABP-671-DDI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no need at present.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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