A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Multiple Dose: Tmax
研究概览
简要总结
This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Only females of non-childbearing potential
- •Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg. Gastrectomy, cholecystectomy).
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
- •Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
- •Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
- •History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
- •Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
研究组 & 干预措施
PF-06651600
PF-06651600 200 milligrams(mg) once daily for 10 days
干预措施: PF-06651600 (Drug)
结局指标
主要结局
Multiple Dose: Tmax
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: AUCtau (tau = 24 hours)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: average concentration at steady state (Cav)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough fluctuation (PTF)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: apparent volume of distribution at steady state (Vss/F)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Single dose: time to reach maximum concentration (Tmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: t1/2
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: mean residence time (MRT)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: predicted accumulation ratio to estimate linearity (Rss)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
时间窗: From Day1 till Day17
Number of participants with clinically significant change in vital signs from Baseline
时间窗: From Day1 till Day17
Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: terminal half life (t1/2)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent volume of distribution (Vz/F)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent oral clearance (CL/F)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: MRT
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Single dose: maximum observed concentration (Cmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose:AUC24
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: Cmax
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on AUCtau (Rac)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)
时间窗: From Day1 till Day17
Multiple Dose: lowest concentration observed during the dosing interval (Cmin)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: CL/F
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough swing (PTS)
时间窗: 0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of participants with clinically significant abnormalities in physical examination findings
时间窗: From Day1 till Day17
次要结局
未报告次要终点