NCT01314898已完成1 期
A Phase 1, Double-Blind (Sponsor-Open), Placebo- And Active-Controlled, Single Dose, Crossover Study To Assess Antimineralocorticoid Activity Of Oral Pf-03882845 In Healthy Subjects.
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
- 12
- 试验地点
- 1
- 主要终点
- Twenty-four hour urinary Na/K ratio (AUC(0-24)).
研究概览
简要总结
24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, diet restrictions and other trial procedures.
排除标准
- •Subjects with a supine BP >140 mm Hg systolic or >90 mm Hg diastolic or <100 mm Hg systolic or <60 mm Hg diastolic based on the average of the triplicate
- •Serum potassium >=5.1 mmol/L or <3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
- •Estimated GFR <60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.
研究组 & 干预措施
Treatment
Experimental
干预措施: Spironolactone (Drug)
Treatment
Experimental
干预措施: 3 mg PF-03882845 (Drug)
Treatment
Experimental
干预措施: 10 mg PF-03882845 (Drug)
Treatment
Experimental
干预措施: 30 mg PF-03882845 (Drug)
Treatment
Experimental
干预措施: 100 mg PF-03882845 (Drug)
结局指标
主要结局
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
时间窗: 0-24hr postdose per period
次要结局
- Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.(0-24 hr post dose per period)
- Time of Maximum concentration(Tmax) of PF-03882845.(0-24 hr post dose per period)
- Maximum concentration (Cmax) of PF-03882845.(0-24 hr post dose per period)
- Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.(2 months)
研究者
研究点 (1)
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