An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Safety Endpoints include: AEs, vital signs, triplicate ECGs,
研究概览
简要总结
This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.
详细描述
To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer aged 65-80 years old
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
- •Total body weight >50 kg (110 lbs).
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).
- •Subjects with symptoms or signs of adrenal insufficiency.
- •Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
研究组 & 干预措施
Dosing
Ascending Doses
干预措施: PF-03382792 0.5mg (Drug)
Dosing
Ascending Doses
干预措施: PF-03382792 1.5 mg (Drug)
Dosing
Ascending Doses
干预措施: PF-03382792 5 mg (Drug)
Dosing
Ascending Doses
干预措施: PF-03382792 15 mg (Drug)
结局指标
主要结局
Safety Endpoints include: AEs, vital signs, triplicate ECGs,
时间窗: Day 0 to Day 28
Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations
时间窗: Day 0 to Day 28
Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.
时间窗: Day 0 to Day 28
Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.
时间窗: Day 0 to Day 28
Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),
时间窗: Day 0 to Day 28
次要结局
未报告次要终点