ABP-671 added to allopurinol in adults with gout
Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
This will test whether adding ABP-671 changes blood levels of allopurinol in adults with gout who are already taking a stable dose of allopurinol.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Atom Therapeutics Co., Ltd Industry-sponsored |
| Locations | 1 site (Cary, North Carolina) |
| Trial ID | NCT07367971 on ClinicalTrials.gov |
What this trial studies
This open-label, within-subject study adds ABP-671 to participants who are already on stable once-daily allopurinol and measures drug concentrations over time to detect pharmacokinetic interactions. Participants are enrolled into cohorts based on renal function (normal or moderate impairment) to evaluate whether kidney function affects the interaction. Serial blood sampling will be used to compare PK parameters with and without ABP-671. The trial is sponsored by Atom Therapeutics and conducted at Wakefield Clinical Research in Cary, North Carolina.
Who should consider this trial
Good fit: Adults aged 18–75 with a clinical diagnosis of gout who have been on stable once-daily allopurinol for at least 14 days and meet the normal or moderate renal function criteria are the intended participants.
Not a fit: Individuals with clinically significant hepatic impairment, a history of allopurinol hypersensitivity, severe renal impairment, or who are pregnant or breastfeeding would be excluded and would not benefit from participation.
Why it matters
Potential benefit: If no clinically important interaction is found, the results could support safe co-use of ABP-671 with allopurinol or inform dose adjustments to reduce risk.
How similar studies have performed: Pharmacokinetic drug-drug interaction studies are a standard and typically successful part of drug development for gout treatments, although ABP-671-specific DDI data are not yet available.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cary, North Carolina
- Wakefield Clinical Research — Cary, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: MaoE Sun
- Email: mao.e.sun@atombp.com
- Phone: 13914017855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.