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;
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Wakefield Clinical Research
Cary
North Carolina
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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