A Phase 1, Randomised, Open Label, Two Sequence, Two Treatment, Two Way Crossover Study to Estimate the Steady-state Effect of Erythromycin on the Single Dose Pharmacokinetics of Ph-797804 in Healthy Subjects
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
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate the effect of co-administration with erythromycin on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 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 measurements, 12-lead ECG and clinical laboratory tests.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a 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).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 21 drinks/week for males.
研究组 & 干预措施
PH-797804 6 mg
Subjects will receive a single 6 mg dose in the fed state
干预措施: PH-797804 (Drug)
PH-797804 6 mg + erythromycin 800 mg
Subjects will receive multiple 800 mg doses of erythromycin and a single 6 mg dose of PH-797804 in the fed state
干预措施: PH-797804 + erythromycin (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Plasma Decay Half-Life (t1/2)
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0,1,2,3,4,6,8,12,24,48,72,96,120,144,168,192,216,240 hours post-dose
次要结局
未报告次要终点