NCT02815839已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight≥50, BMI:19-24kg/m2;
- •Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
- •Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
排除标准
- •History of hyperuricemia or gout.
- •Pregnancy or breastfeeding;
- •History or suspicion of kidney stones;
- •serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;
- •alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.
研究组 & 干预措施
Cohort 5
Experimental
20-mg SHR4640 or placebo
干预措施: Placebo (Drug)
Cohort 3
Experimental
7.5-mg SHR4640 or placebo
干预措施: SHR4640 (Drug)
Cohort 3
Experimental
7.5-mg SHR4640 or placebo
干预措施: Placebo (Drug)
Cohort 4
Experimental
10-mg SHR4640 or placebo
干预措施: SHR4640 (Drug)
Cohort 4
Experimental
10-mg SHR4640 or placebo
干预措施: Placebo (Drug)
Cohort 5
Experimental
20-mg SHR4640 or placebo
干预措施: SHR4640 (Drug)
Cohort 2
Experimental
5-mg SHR4640 or placebo
干预措施: Placebo (Drug)
Cohort 1
Experimental
2.5-mg SHR4640 or placebo
干预措施: SHR4640 (Drug)
Cohort 1
Experimental
2.5-mg SHR4640 or placebo
干预措施: Placebo (Drug)
Cohort 2
Experimental
5-mg SHR4640 or placebo
干预措施: SHR4640 (Drug)
结局指标
主要结局
Adverse events
时间窗: Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
次要结局
- Area under the plasma concentration versus time curve (AUC)(up to day 4; up to day 11 for 7.5mg dose group)
- Half-time (T1/2)(up to day 4; up to day 11 for 7.5mg dose group)
- AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group(up to day 11)
- Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group(up to day 11)
- Changes in serum uric acid concentration from baseline(up to day 4; up to day 11 for 7.5mg dose group)
- Changes in urinary uric acid excretion from baseline(up to day 4; up to day 11 for 7.5mg dose group)
- Peak Plasma Concentration (Cmax)(up to day 4; up to day 11 for 7.5mg dose group)
- Time to the peak plasma concentration (Tmax)(up to day 4; up to day 11 for 7.5mg dose group)
- Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group(up to day 11)
- T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group(up to day 11)
研究者
研究点 (1)
Loading locations...
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