NCT04155918已完成2 期
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of AR882 Administered Alone or in Combination With Febuxostat or Allopurinol in Gout Patients
Arthrosi Therapeutics1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum uric acid (sUA) response rate
研究概览
简要总结
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of gout
- •sUA > 7 mg/dL
- •Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2
排除标准
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •Active peptic ulcer disease or active liver disease
- •History of kidney stones
- •Allergy or intolerance to colchicine, febuxostat, and allopurinol
结局指标
主要结局
Serum uric acid (sUA) response rate
时间窗: 22 Days
sUA response rate to achieve sUA \<6, \<5, \<4, and \<3 mg/dL
PD profile of AR882 administered alone or in combination with febuxostat
时间窗: 22 Days
Profile from serum uric acid concentration over time
PD profile of AR882 administered alone or in combination with allopurinol
时间窗: 22 Days
Profile from serum uric acid concentration over time.
次要结局
- t1/2 for for colchicine(22 Days)
- Maximum plasma concentration (Cmax) for AR882(22 Days)
- Amount excreted (Ae) into urine for AR882(22 Days)
- Area under the curve (AUC) for plasma AR882(22 Days)
- Time to maximum plasma concentration (Tmax) for AR882(22 Days)
- Renal clearance (CLr) for AR882(22 Days)
- Tmax for febuxostat(22 Days)
- AUC for plasma allopurinol/oxypurinol(22 Days)
- Apparent terminal half-life (t1/2) for AR882(22 Days)
- Incidence of Adverse Events, changes in laboratory, electrocardiogram, and vital signs(28 Days)
- Cmax for febuxostat(22 Days)
- t1/2 for febuxostat(22 Days)
- Tmax for allopurinol/oxypurinol(22 Days)
- Tmax for colchicine(22 Days)
- Cmax for colchicine(22 Days)
- AUC for plasma for febuxostat(22 Days)
- Cmax for allopurinol/oxypurinol(22 Days)
- t1/2 for for allopurinol/oxypurinol(22 Days)
- Ae in urine for allopurinol/oxypurinol(22 Days)
- CLr for allopurinol/oxypurinol(22 Days)
- AUC for plasma for colchicine(22 Days)
研究者
研究点 (1)
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