A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax of warfarin with MT-3995 versus warfarin alone
研究概览
简要总结
The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin
详细描述
The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide written informed consent to participate in this study
- •Healthy, free from clinically significant illness or disease
- •White Caucasian male or female, aged 18 to 55 years
- •Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)
- •Must have coagulation test results (including international normalised ratio [INR] and activated partial thromboplastin time [aPTT]) within the laboratory reference range at Screening.
排除标准
- •Presence or history of serious adverse reaction or allergy to any medicinal product
- •Known contraindication or adverse reaction to warfarin.
- •Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.
- •Known contraindications to heparin administration.
- •Known contraindication to parenteral vitamin K administration.
研究组 & 干预措施
Warfarin and MT-3995
Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27.
干预措施: MT-3995 (Drug)
Warfarin and MT-3995
Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27.
干预措施: Warfarin (Drug)
结局指标
主要结局
Cmax of warfarin with MT-3995 versus warfarin alone
时间窗: 8 days
AUC of warfarin with MT-3995 versus warfarin alone
时间窗: 8 days
次要结局
- INR AUC of warfarin with MT-3995 versus warfarin alone(8 days)
- International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone(8 days)