A Phase 1, Single-Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUClast)
研究概览
简要总结
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable renal function defined as <20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
- •Body Mass Index (BMI) of 17.5 to 40 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, and other study procedures.
排除标准
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
- •Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).
- •Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.
- •Subjects with acute renal disease.
研究组 & 干预措施
healthy controls
healthy subjects (creatinine clearance > 90 mL/min)
干预措施: PF-04991532 (Drug)
ESRD / severe renal insufficiency
Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace <15 mL/min OR requiring dialysis)
干预措施: PF-04991532 (Drug)
Moderate renal impairment
Moderate (creatinine clearance = 30 to 59 mL/min)
干预措施: PF-04991532 (Drug)
Mild renal impairment
Mild (creatinine clearance = 60 to 89 mL/min)
干预措施: PF-04991532 (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUClast)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Maximum observed plasma concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Time of maximum observed plasma concentration (Tmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hrs
Renal Clearance (Clr)
时间窗: 0 to 24 hours
Amount of drug excreted (Ae)
时间窗: 0 to 24 hours
次要结局
未报告次要终点