A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered Pf 06650833 In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment emergent adverse events.
研究概览
简要总结
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 female subjects of non childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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 the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- •Smokers must not exceed the equivalent of 5 cigarettes per day.
- •Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
- •Screening supine blood pressure100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140 mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest. If blood pressure (BP) is 40 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility.
- •Screening pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR is >100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility.
- •Screening 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
- •Clinically significant abnormality on chest X ray performed at screening or within 3 months of screening date.
- •History of tuberculosis or active or latent or inadequately treated infection, positive Quantiferon TB test
- •History of hepatitis or HIV, positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HepBsAg), hepatitis B core antibodies (HepBcAb) or hepatitis C antibodies (HCVAb).
研究组 & 干预措施
PF-06650833
Active arm , PF-06650833 kinase.
干预措施: PF-06650833 (Drug)
Placebo
Placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of treatment emergent adverse events.
时间窗: 50 days
Incidence and Magnitude of Participants with Treatment-emergent chemistry abnormalities (including, cardiac enzymes CK, CK-MB and cardiac Troponin-1, serum myoglobin)
时间窗: 50 days
Incidence and Magnitude of Participants with Treatment-emergent urinalysis abnormalities
时间窗: 50 Days
Changes from baseline in blood pressure
时间窗: 50 days
Changes from baseline in pulse rate
时间窗: 50 days
Changes from baseline in respiratory rate
时间窗: 50 days
Changes from baseline in ECG parameters (standard 12-lead ECG)
时间窗: 50 days
Changes from baseline in Epstein-Barr virus [EBV]
时间窗: 50 days
Changes from baseline in Cytomegalovirus [CMV]
时间窗: 50 days
Changes from baseline in Herpes simplex virus-1 and -2 [HSV-1 and HSV-2]
时间窗: 50 days
Incidence and Magnitude of Participants with Treatment-emergent hematology clinical abnormalities
时间窗: 50 days
次要结局
- To characterize Cmax in plasma(Day 1 and Day 14)
- To determine PF-06650833 excreted unchanged (AE tau and AE tau %),(Day 14)
- To characterize Tmax in plasma(Day 1 and Day 14)
- To characterize AUC tau in plasma(Day 1 and Day 14)
- To characterize Cmin in plasma(Day 1 and Day 14)
- Characterize Cmax (dose normalized) in plasma(Day 1 and Day 14)
- To characterize AUC tau(dose normalized) in plasma(day1 and day 14)
- To determine the renal clearance (CLr)(Day 14)