A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
研究概览
简要总结
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a body mass index ≥18.5 and ≤30 kg/m2;
- •Screening sUA value ≥8mg/dl;
- •Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
排除标准
- •Subject known or suspected of being sensitive to the study drugs or its ingredient；
- •History of kidney stones or screening kidney stones by B-ultrasound；
- •History of malignancy within 5 years；
- •History of xanthinuria；
- •Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。
研究组 & 干预措施
Cohort 1
Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd.
干预措施: Colchicine (Drug)
Cohort 1
Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd.
干预措施: Febuxostat (Drug)
Cohort 1
Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd.
干预措施: SHR4640 (Drug)
结局指标
主要结局
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
时间窗: Clinical significant changes from baseline up to Day 8
PK profile
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
时间窗: Clinical significant changes from baseline up to Day 8
PK profile
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
时间窗: Clinical significant changes from baseline up to Day 8
PK profile
次要结局
- Changes in Laboratory Values(Clinical significant changes from Day-14 up to Day 16)
- Changes in Electrocardiogram(Clinical significant changes from Day-14 up to Day 16)
- Changes in Vital Signs Parameters(Clinical significant changes from Day-14 up to Day 16)
- Incidence of Adverse events(Clinical significant changes from Day-14 up to Day 16)