NCT02070289已完成1 期
A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of Pf-06372865 In Subjects Aged 18-55 (Group 1) And 56-75 Years (Group 2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06372865 for 14 days in healthy subjects of two age groups, 18-55 years (Group 1) and 56-75 years (Group 2).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive at Screening. 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.
- •For Group 2 specific: Male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive at Screening. Subjects must be in reasonably good health as determined by the Investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the Investigator. At least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
- •For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.
排除标准
- •For Group 1 specific: 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).
- •For Group 2 specific : Evidence or history of unstable disease or moderate to severe conditions which would, in the Investigator's opinion, interfere with the study evaluations or impact on the safety of participating subjects, such as orthostatic hypotension.
- •Subjects with history of sleep apnea
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
Group 1 or 2: Cohort 6
Experimental
干预措施: PF-06372865 (Drug)
Group 1: Cohort 1
Experimental
干预措施: PF-06372865 (Drug)
Group 1: Cohort 1
Experimental
干预措施: Placebo (Drug)
Group 1: Cohort 2
Experimental
干预措施: PF-06372865 (Drug)
Group 1: Cohort 2
Experimental
干预措施: Placebo (Drug)
Group 1: Cohort 3
Experimental
干预措施: PF-06372865 (Drug)
Group 1: Cohort 3
Experimental
干预措施: Placebo (Drug)
Group 2: Cohort 4
Experimental
干预措施: PF-06372865 (Drug)
Group 2: Cohort 4
Experimental
干预措施: Placebo (Drug)
Group 1 or 2: Cohort 5
Experimental
干预措施: PF-06372865 (Drug)
Group 1 or 2: Cohort 5
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
时间窗: 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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