Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07367971

Drug-Drug Interaction Study of ABP-671 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gout Chronic Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies DDI (Drug-Drug Interaction) Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wakefield Clinical Research

Cary, North Carolina, 27560, United States

Location status: Recruiting

Location contact

Xiaohuan Li, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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；

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

MaoE Sun

CONTACT

[email protected]

13914017855

Sponsors and collaborators

Lead sponsor

Atom Therapeutics Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.