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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07367971

Enrollment

Registered

2026-01-26

Start date

2026-01-23

Completion date

2026-08-31

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

gout, Gout Chronic, ABP-671

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.

Interventions

DRUGABP-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；

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum plasma concentration (Cmax) of allopurinol	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.
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol	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

Measure	Time frame	Description
Maximum plasma concentration (Cmax) of ABP-671	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.
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671	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.
Incidence of treatment-emergent adverse events (TEAEs)	Through study completion, an average of 51 days	Number and percentage of participants experiencing treatment-emergent adverse events.

Countries

United States

Contacts

CONTACTMaoE Sun

mao.e.sun@atombp.com13914017855

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026