Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of allopurinol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-75 years with clinical diagnosis of gout.
- •Stable Allopurinol therapy QD for ≥14 days prior to Day
- •Cohort N: Normal renal function.
- •Cohort R: Moderate renal impairment.
排除标准
- •Clinically significant hepatic impairment.
- •History of Allopurinol hypersensitivity.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
ABP-671
干预措施: ABP-671 plus allopurinol (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of allopurinol
时间窗: 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
时间窗: 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.
次要结局
- Maximum plasma concentration (Cmax) of ABP-671(Though Day7,Day8,Day14,Day15,Day21)
- Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671(Though Day7,Day8,Day14,Day15,Day21)
- Incidence of treatment-emergent adverse events (TEAEs)(Through study completion, an average of 51 days)