Drug-Drug Interaction Study of ABP-671 in Gout Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAtom Therapeutics Co., Ltd
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Clinically significant hepatic impairment.
History of Allopurinol hypersensitivity.
Pregnancy or breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
ABP-671 plus allopurinol
DrugAll 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；
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ABP-671Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Base line, through Day1, Day 7,Day8,D14,D15,D212
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.
Time frame
Base line, through Day1, Day 7,Day8,D14,D15,D21Secondary outcomes
1
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.
Time frame
Though Day7,Day8,Day14,Day15,Day212
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.
Time frame
Though Day7,Day8,Day14,Day15,Day213
Incidence of treatment-emergent adverse events (TEAEs)
Number and percentage of participants experiencing treatment-emergent adverse events.
Time frame
Through study completion, an average of 51 daysSponsors and contacts
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Source ClinicalTrials.gov