A Phase 1, Open-label Study In Healthy Subjects To Investigate the Pharmacokinetics Of Pf-06412562 Following Single Oral Administration Of Modified Release Formulation In Fasted And Fed States
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
- Time after dose and before the first plasma concentration (Tlag)
研究概览
简要总结
The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
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 of non-childbearing potential 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).
- •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.
- •Subjects who have attempted suicide in the past.
- •Subjects who have an unexplained history of sudden death in their family
研究组 & 干预措施
Arm 1
干预措施: 3 mg PF-06412562 MR tablets_Fasted (Drug)
2
干预措施: 2 x 15 mg PF-06412562 MR tablets_Fasted (Drug)
3
干预措施: 2 x 15 mg PF-06412562 MR tablets_Fed (Drug)
4
干预措施: 10 mg PF-06412562 IR tablets (Drug)
结局指标
主要结局
Time after dose and before the first plasma concentration (Tlag)
时间窗: 0-2
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-2 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
时间窗: 0- 2 days
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
时间窗: 0-2 days
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Plasma Decay Half-Life (t1/2)
时间窗: 0-2 days
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0-2 days
次要结局
未报告次要终点