NCT01854996已完成1 期
A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers
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
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
研究概览
简要总结
This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Healthy male and/or female subjects 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 pulse rate measurement, 12-lead ECG and clinical laboratory tests). 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).
- •An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), 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)
研究组 & 干预措施
Oral disperion fasted
Experimental
A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.
干预措施: PF-05089771 (Drug)
Capsule fasted
Experimental
single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions
干预措施: PF-05089771 (Drug)
Capsule fed
Experimental
single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions
干预措施: PF-05089771 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 48 hours
次要结局
- Number of Participants With Laboratory Test Values of Potential Clinical Importance(48 hours)
研究者
研究点 (1)
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