A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
研究概览
简要总结
This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
详细描述
This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female, 18-45 years old, inclusive;
- •BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.
- •Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.
排除标准
- •Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);
- •History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;
- •Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;
- •History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;
- •History of acute or chronic pancreatitis;
- •History of documented or suspected hypoglycemic episodes within 6 months prior to screening;
研究组 & 干预措施
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment
Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: XW003 injection (Drug)
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment
Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: Metformin (Drug)
Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment
Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: Warfarin (Drug)
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment
Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: XW003 injection (Drug)
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment
Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: Rosuvastatin (Drug)
Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment
Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.
干预措施: Digoxin (Drug)
结局指标
主要结局
Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf
时间窗: up to 114 days
Pharmacokinetics of metformin: AUC0-inf
时间窗: up to 101 days
Pharmacokinetics of rosuvastatin: AUC0-inf
时间窗: up to 102 days
Pharmacokinetics of digoxin: AUC0-inf
时间窗: up to 112days
次要结局
未报告次要终点