[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07367971":3,"trial-entities:NCT07367971":98,"trial-summary:NCT07367971":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":46,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":72,"locations":75,"central_contacts":89,"overall_officials":95,"references":96,"see_also_links":97},"NCT07367971","ABP-671-DDI-01","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","RECRUITING","2026-08-31","2026-04","2026-04-14","2026-01-23","Atom Therapeutics Co., Ltd","INDUSTRY",false,"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.",null,[19,20,21],"Gout Chronic","Gout","DDI (Drug-Drug Interaction)",[23,19,24],"gout","ABP-671","INTERVENTIONAL","TREATMENT",[28],"PHASE1",{"count":30,"type":31},20,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","ABP-671 plus allopurinol","All subjects undergo three sequential 7-day periods:\n\nPeriod 1 (Day 1-7): Allopurinol；\n\nPeriod 2 (Day 1-7): Allopurinol Plus ABP-671；\n\nPeriod 3 (Day 1-7): ABP-671；",[24],[39,43],{"measure":40,"description":41,"timeFrame":42},"Maximum plasma concentration (Cmax) of allopurinol","Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.","Base line, through Day1, Day 7,Day8,D14,D15,D21",{"measure":44,"description":45,"timeFrame":42},"Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol","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.",[47,51,54],{"measure":48,"description":49,"timeFrame":50},"Maximum plasma concentration (Cmax) of ABP-671","Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.","Though Day7,Day8,Day14,Day15,Day21",{"measure":52,"description":53,"timeFrame":50},"Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671","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.",{"measure":55,"description":56,"timeFrame":57},"Incidence of treatment-emergent adverse events (TEAEs)","Number and percentage of participants experiencing treatment-emergent adverse events.","Through study completion, an average of 51 days","ALL","18 Years","75 Years",{"inclusion":62,"exclusion":67,"raw_text":71},[63,64,65,66],"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.",[68,69,70],"Clinically significant hepatic impairment.","History of Allopurinol hypersensitivity.","Pregnancy or breastfeeding.","Inclusion Criteria:\n\n* Adults 18-75 years with clinical diagnosis of gout.\n* Stable Allopurinol therapy QD for ≥14 days prior to Day 1.\n* Cohort N: Normal renal function.\n* Cohort R: Moderate renal impairment.\n\nExclusion Criteria:\n\n* Clinically significant hepatic impairment.\n* History of Allopurinol hypersensitivity.\n* Pregnancy or breastfeeding.",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":86},"Wakefield Clinical Research","Cary","North Carolina","27560","United States",[83],{"name":84,"role":85},"Xiaohuan Li, MD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},35.79154,-78.78112,[90],{"name":91,"role":92,"phone":93,"email":94},"MaoE Sun","CONTACT","13914017855","mao.e.sun@atombp.com",[],[],[],{"nct_id":4,"conditions":99,"biomarkers":100},[20],[],{"nct_id":4,"found":102,"summary":103,"prompt_version":112},true,{"design":104,"status":105,"heading":6,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an open-label study with about 20 participants. Each participant will receive allopurinol, then allopurinol plus ABP-671, and finally ABP-671 alone, each for 7 days.","completed","This study is looking at how a new drug, ABP-671, interacts with allopurinol, a common medication for gout. If you have gout and are currently taking allopurinol, you might be able to join. The study will measure the levels of allopurinol in your blood at different times to see if ABP-671 changes how your body handles allopurinol. We're looking for about 20 adults, aged 18 to 75, with a diagnosis of gout. The study is open-label, meaning both you and the study team will know which medications you are taking. The goal is to understand how these two drugs work together.","Blood levels of allopurinol will be measured up to Day 21.",101,"You would take allopurinol for 7 days, then allopurinol plus ABP-671 for 7 days, and then ABP-671 alone for 7 days. Blood samples will be taken at baseline and on specific days throughout the study (Day 1, 7, 8, 14, 15, 21).","Not stated in the trial record.",[],"v2"]