NCT04390776已完成1 期
A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS
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
- 164
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
研究概览
简要总结
The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.
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
- •Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
- •BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, 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).
- •Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- •Participants with any of the following acute or chronic infections or infection history:
- •Any infection requiring treatment within 2 weeks prior to the dosing visit.
- •Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
- •Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
- •Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
- •History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.
研究组 & 干预措施
Treatment Sequence 2
Experimental
PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).
干预措施: PF-06651600 (Drug)
Treatment Sequence 3
Experimental
PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).
干预措施: PF-06651600 (Drug)
Treatment Sequence 1
Experimental
PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).
干预措施: PF-06651600 (Drug)
Treatment Sequence 4
Experimental
PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).
干预措施: PF-06651600 (Drug)
结局指标
主要结局
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
时间窗: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Maximum plasma PF-06651600 concentration (C max)
时间窗: Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
次要结局
- Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
- Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
- Single dose plasma decay half-life (t 1/2) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
- Single dose Apparent Oral Clearance (CL/F) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
- Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600(Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.)
- Frequency of abnormal safety laboratory tests(Baseline up to day 9)
- Frequency of Adverse Events(Baseline up to day 35)
研究者
研究点 (2)
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