A Phase 1, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of FG 4592 on the Pharmacokinetics of Warfarin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- PK of S-warfarin and R-warfarin in plasma measured by maximum concentration (Cmax)
研究概览
简要总结
This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin alone and in combination with multiple doses of FG-4592, and will evaluate the effect of multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.
详细描述
The study consists of 2 periods, separated by a washout period (a minimum of 14 days after warfarin dosing on Day 1, Period 1). Screening takes place from Day -22 to Day -2.
Subjects are admitted to the clinical unit on Day -1 of Period 1. On Day 1 of the first period, subjects receive a single oral dose of warfarin. After completion of all assessments on Day 8, subjects are discharged from the clinical unit on the condition that there are no medical reasons for a prolonged stay. They return to the clinical unit on Day -1 of the second period, after the washout period.
In Period 2, the subjects receive multiple doses of FG 4592. On Day 7 of Period 2, FG 4592 is given concomitantly with warfarin. After completion of all assessments on Day 16 of Period 2, subjects are discharged from the clinic on the condition that there are no medical reasons for a prolonged stay. The subjects return for an End of Study Visit (ESV) 5 to 9 days after the last assessment of Period 2 (or after early withdrawal).
Safety assessments are performed throughout the study. Blood and urine samples are collected for PK and PD assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control.
- •Male subject must not donate sperm starting at screening and throughout the study period and for 90 days after the final study drug administration.
- •Female subject must be either of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test at screening and Day -1 and must use two forms of birth control.
- •Female subject must not donate ova starting at screening and throughout the study period and for 28 days after the final study drug administration.
排除标准
- •Subject has a known or suspected hypersensitivity to FG 4592, warfarin, or any components of the formulations used.
- •Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to admission to the clinical unit [Day -1].
- •Subject is lactose intolerant.
研究组 & 干预措施
warfarin and FG-4592
Single dose of warfarin and Multiple doses of FG-4592 in combination with a single dose of warfarin
干预措施: Warfarin (Drug)
warfarin and FG-4592
Single dose of warfarin and Multiple doses of FG-4592 in combination with a single dose of warfarin
干预措施: FG-4592 (Drug)
结局指标
主要结局
PK of S-warfarin and R-warfarin in plasma measured by maximum concentration (Cmax)
时间窗: Period 1 (Day 1 to Day 8); Period 2 (Day 7 to Day 16)
PK of S-warfarin and R-warfarin in plasma measured by area under the curve from the time of dosing extrapolated to time infinity (AUCinf)
时间窗: Period 1 (Day 1 to Day 8); Period 2 (Day 7 to Day 16)
次要结局
- Safety profile(Screening (Day -22 to Day -2) to ESV (5 to 9 days after the last protocol defined assessment of Period 2 (or after early withdrawal)))
- PK profile of FG-4592 in plasma(Period 2 (Day 1 to Day 15))
- PK profile of S-warfarin and R-warfarin in plasma(Period 1 (Day 1 to Day 8); Period 2 (Day 7 to Day 16))
- Pharmacodynamics profile of warfarin in plasma(Period 1 Day 1 to to ESV (5 to 9 days after the last protocol defined assessment of Period 2 (or after early withdrawal)))
- PK profile of FG-4592 in urine(Period 2 (Day 7 to Day 8))