A Phase 1 Double Blind (3rd Party Open) Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses Of Pf-06743649 In Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Renal clearance (CLr)
研究概览
简要总结
The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.
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
- 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 between the ages of 65 and 85 years, inclusive. Ideally at least 25% of the subjects enrolled in each cohort will be 75 years of age and above at Screening. Subjects must be healthy 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 test results. Subjects with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the investigator.
- •Body Mass Index (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 the subject (or a legally acceptable representative) 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 drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Evidence of gout/hyperuricemia, measured sUA >8 mg/dL at screening.
- •Experienced an episode of nephrolithiasis or ureterolithiasis.
研究组 & 干预措施
Cohort 1-PF-06743649 or placebo
干预措施: PF-06743649 (Drug)
Cohort 1-PF-06743649 or placebo
干预措施: Placebo (Drug)
Cohort 2-PF-06743649 or placebo
干预措施: PF-06743649 (Drug)
Cohort 2-PF-06743649 or placebo
干预措施: Placebo (Drug)
Cohort 3-PF-06743649 or placebo
干预措施: PF-06743649 (Drug)
Cohort 3-PF-06743649 or placebo
干预措施: Placebo (Drug)
Cohort 4-PF-06743649 or placebo
干预措施: PF-06743649 (Drug)
Cohort 4-PF-06743649 or placebo
干预措施: Placebo (Drug)
Cohort 5-PF-06743649 or placebo
干预措施: PF-06743649 (Drug)
Cohort 5-PF-06743649 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Renal clearance (CLr)
时间窗: up to 14 days
Maximum Observed Plasma Concentration (Cmax)
时间窗: up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
时间窗: up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: up to 14 days
Plasma Decay Half-Life (t1/2)
时间窗: up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
时间窗: up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
时间窗: up to 14 days
次要结局
- Urinary uric acid levels(up to 14 days)
- Change from baseline in serum uric acid level(up to 14 days)
- Change from baseline in serum levels of xanthine and hypoxanthine(up to 14 days)
- Urinary xanthine levels(up to 14 days)
- Urinary hypoxanthine levels(up to 14 days)