A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled First-in-human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06648671 After Administration Of Single Ascending Doses To Fasted And Fed Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of participants with AEs and SAEs
研究概览
简要总结
This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 male and/or female subjects of non childbearing potential
- •BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
- •Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drg allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing);
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
研究组 & 干预措施
Single Ascending Doses Cohort 1
subjects receive 3 active doses and one placebo
干预措施: PF-06648671 (Drug)
Single Ascending Doses Cohort 1
subjects receive 3 active doses and one placebo
干预措施: Placebo (Drug)
Single Ascending Doses Cohort 2
subjects receive 3 doses and one placebo
干预措施: PF-06648671 (Drug)
Single Ascending Doses Cohort 2
subjects receive 3 doses and one placebo
干预措施: Placebo (Drug)
Cohort 3
optional cohort
干预措施: PF-06648671 (Drug)
Cohort 3
optional cohort
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with AEs and SAEs
时间窗: 0-6 weeks
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurences of an AE within a category will be counted once within the category
Supine vital sign measurement
时间窗: 0-6 weeks
Measurement of blood pressure and pulse rate
Electrocardiogram (ECG)
时间窗: 0-6 weeks
Measurement of standard 12-lead ECG, single or triplicate
Number of participants with lab test values of potential clinical importance
时间窗: 0-6 weeks
Pre-defined criteria were established for each lab test to identify potential clinical importance
次要结局
- Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)(0-72 hours post-dose)
- Plasma Abeta40 Maximum change from baseline(0-72 hours post dose)
- Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)(0-72 hours post dose)
- Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)(0-72 hours post-dose)
- Maximum Observed Plasma Concentration (Cmax)(0-72 hours post dose)
- Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)(0-72 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)(0-72 hours post dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0-72 hours post dose)
- Plasma Decay Half-life (t1/2)(0-72 hours post dose)
- Apparent Oral Clearance (CL/F)(0-72 hours post dose)
- Apparent Volume of Distribution (Vz/F)(0-72 hours post dose)
- Plasma Cmax ratio under fed vs fasted conditions(0-72 hours post dose)
- Plasma AUClast ratio under fed vs fasted condition(0-72 hours post dose)
- Plasma AUCinf ratio under fed vs fasted conditions(0-72 hours post dose)
- Plasma Abeta42 Maximum change from baseline(0-72 hours post dose)
- Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)(0-72 hours post dose)