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Recruiting NCT07367971

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

Phase I Interventional Gout Chronic Gout DDI (Drug-Drug Interaction)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABP-671 plus allopurinol.
Who it may be relevant to
Registry conditions: Gout Chronic, Gout, DDI (Drug-Drug Interaction). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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；

Primary outcome measures

  • Maximum plasma concentration (Cmax) 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 [Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21]
Secondary outcome measures (3)
  • Maximum plasma concentration (Cmax) 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 [Time frame: Though Day7,Day8,Day14,Day15,Day21]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Through study completion, an average of 51 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wakefield Clinical Research — Cary

Identifiers

NCT: NCT07367971 · ABP-671-DDI-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗