An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 Up To An Exposure Cap In Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests
研究概览
简要总结
Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects.
- •Subjects must be in reasonably good health as determined by the investigator based on 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, controlled hypertension, non-insulin dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the investigator.
- •Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose.
- •Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight >50 kg (110 lbs).
- •Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.
排除标准
- •Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, or allergic disease.
- •Use of tobacco or any form of nicotine in the past 6 months.
- •Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of alcohol per week for men.
研究组 & 干预措施
Cohort 2
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
干预措施: PF-04447943 (Drug)
Cohort 1
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
干预措施: PF-04447943 (Drug)
Cohort 3a
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
干预措施: PF-04447943 (Drug)
Cohort 3b
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
干预措施: PF-04447943 (Drug)
Cohort 4
干预措施: PF-04447943 (Drug)
结局指标
主要结局
Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests
时间窗: For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax)
时间窗: For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14
Maximum plasma concentration (Cmax)
时间窗: 1 hour post dose day 4
Minimum plasma concentration ((Ctrough)
时间窗: For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13
Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses
时间窗: For cohorts 1-3, day 7; for cohort 4, day 14
次要结局
- CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score(For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.)