A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Rising Dose Study of AR882, a Potent Uricosuric Agent, in Healthy Adult Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Time to maximum plasma concentration (Tmax) for AR882
研究概览
简要总结
A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Serum uric acid level ≥ 4.5 mg/dL (268 µmol/L)
- •Body weight no less than 50 kg and body mass index (BMI) within the range of ≥18 and ≤33 kg/m2
- •Must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures
排除标准
- •Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
- •History of cardiac abnormalities
- •History and/or presence of drug addiction or excessive use of alcohol
结局指标
主要结局
Time to maximum plasma concentration (Tmax) for AR882
时间窗: 6 Days
Profile from plasma in terms of Tmax for AR882
Apparent terminal half-life (t1/2) for AR882
时间窗: 6 Days
Profile from plasma in terms of t1/2 for AR882
To evaluate the safety profile of AR882 based on incidence of abnormal laboratory findings
时间窗: 8 Days
Analysis of abnormal safety laboratory findings
Area under the curve (AUC) for plasma AR882
时间窗: 6 Days
Profile from plasma in terms of AUC for AR882
Fractional Excretion (FEUA) for AR882
时间窗: 6 Days
Profile from urine in terms of FEUA for AR882
Maximum plasma concentration (Cmax) for AR882
时间窗: 6 Days
Profile from plasma in terms of Cmax for AR882
Amount excreted (Ae) into urine for AR882
时间窗: 6 Days
Profile from urine in terms of Ae for AR882
Safety Analyses
时间窗: 8 Days
ECG Heart Rate
次要结局
- PD profile of a single dose of AR882 in combination with allopurinol(6 Days)
- PD profile of a single dose of AR882 in combination with febuxostat(6 Days)
- PD profile of a single dose of AR882(6 Days)