A Double Blind, Randomized 3rd Party Open, Placebo Controlled, Parallel Group Multiple Oral Escalating Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UK-396,082 In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
研究概览
简要总结
The purpose of this study in healthy people is to investigate the safety, toleration and time course of UK-396,082 concentration in the blood and any changes in relevant markers of drug effects, following multiple doses given twice daily by mouth for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •A positive urine drug screen.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
研究组 & 干预措施
Cohort 1
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: UK-396,082 (Drug)
Cohort 1
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: placebo (Drug)
Cohort 2
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: UK-396,082 (Drug)
Cohort 2
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: placebo (Drug)
Cohort 3
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: UK-396,082 (Drug)
Cohort 3
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: placebo (Drug)
Cohort 4
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: UK-396,082 (Drug)
Cohort 4
Subjects will be assigned to receive either UK-396,082 or placebo
干预措施: placebo (Drug)
结局指标
主要结局
safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
时间窗: 14 days
次要结局
- Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, Rac (=AUCtau (Day 14)/AUCtau (Day 1)), CL/F, Vz/f, Cmin, Cav Urine pharmacokinetics: Aetau & Aetau%, CLR on Day 14(14 days)
- Time course of changes in prothrombin time, activated partial thromboplastin time, TAFi inhibition, fibrinogen and D-dimer concentrations.(14 days)