A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
研究概览
简要总结
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine 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 ≥18.0 and ≤32 kg/m2;
- •Screening sUA value ≥480μmol/L;
- •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；sCr>ULN；
- •History of kidney stones or screening kidney stones by B-ultrasound;
- •History of malignancy；
- •History of xanthinuria；
- •Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
- •ALT or AST > 1.5 x ULN
- •Unstable angina, history of symptomatic arrhythmia, or heart failure
- •HbAlc>8%
- •eGFR<60ml/min/1.73m2
- •Investigational drug within 3 months of study dosing
研究组 & 干预措施
Cohort 1
Colchicine 0.5 mg Oral Tablet Day-7~Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8~Day21 qd.
Interventions:
Drug: Colchicine Drug: Febuxostat Drug: XNW3009
干预措施: Colchicine (Drug)
结局指标
主要结局
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
时间窗: 100 days
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Observed maximum concentration at steady state (Cmax,ss)
时间窗: 100 days
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
次要结局
- Mean Terminal Phase Half-life (t1/2)(100 days)
- Time to Maximum Serum Concentration (Tmax)(100 days)
- Serum or urine Uric Acid Level(100 days)
- Number of Participants With Clinically Significant Laboratory Test Abnormalities(100 days)
- Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)(100 days)
- Serum or urine Creatinine(100 days)