Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
研究概览
简要总结
The purpose of this study is to look at how much warfarin gets into the blood stream and how long it takes the body to get rid of it when given both with and without lanabecestat. Another purpose is to evaluate the effectiveness of warfarin therapy to prevent blood clots when given with lanabecestat by measuring international normalized ratio (INR). INR measures the time it takes for blood to clot and compares it to an average. Information about any side effects that may occur will also be collected. The study will last about 5 weeks from the first dose to follow-up for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Male participants: will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
- •Female participants: women not of childbearing potential
排除标准
- •Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
- •Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
- •Have a history or presence of significant bleeding disorders
- •Have a history of gastrointestinal ulcers with hemorrhage
- •Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
- •Self-reported history of increased bleeding from trauma
- •Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
- •History of major surgery within 3 months of screening
- •Planned surgery within 14 days after the last day of dosing
- •International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
- •Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
- •History of deep vein thrombosis and/or pulmonary embolism
研究组 & 干预措施
Warfarin
Single oral dose of 15 mg warfarin on Day 1.
干预措施: Warfarin (Drug)
Lanabecestat + Warfarin
Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
干预措施: Lanabecestat (Drug)
Lanabecestat + Warfarin
Lanabecestat administered orally once daily on Days 8 to 27, with a single oral dose of 15 mg warfarin co-administered on Day 22.
干预措施: Warfarin (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin
时间窗: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin
时间窗: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22
次要结局
- Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin(Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin(Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22)
- Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin(Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22)
- Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin(Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22)