An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST))
研究概览
简要总结
This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.
详细描述
To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
- •For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. 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, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age.
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).
研究组 & 干预措施
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
干预措施: 0.1 mg PF-04995274 (Drug)
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
干预措施: 1 mg PF-04995274 (Drug)
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
干预措施: 10 mg PF-04995274 (Drug)
Dosing Healthy Adult
Ascending Doses in Healthy Adult Volunteers
干预措施: 15 mg PF-04995274 (Drug)
Dosing Healthy Elderly
Dosing in Healthy Elderly volunteers
干预措施: 1.0 mg PF-04995274 (Drug)
Dosing Healthy Elderly
Dosing in Healthy Elderly volunteers
干预措施: 15 mg PF-04995274 (Drug)
结局指标
主要结局
Safety Endpoints (Adverse events, Change from baseline in vital signs, Change from baseline in triplicate ECGs, Clinical safety laboratory, Clinical examinations, Digit Symbol Substitution Test (DSST))
时间窗: Day 0 to Day 28
Pharmacokinetic endpoints Plasma concentration of PF 04995274 over time (eg, AUC, Cmax, Tmax, t1/2), Plasma concentration of PF 05082547 over time (eg, AUC, Cmax, Tmax, t1/2).
时间窗: Day 0 to Day 28
Pharmacodynamic endpoint Aldosterone concentration in healthy adult subjects.
时间窗: Day 0 to Day 14
次要结局
- No secondary outcomes