NCT03308110已完成1 期
A PHASE 1, SINGLE DOSE, OPEN LABEL, RANDOMIZED, 5-PERIOD CROSSOVER STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY AND FOOD EFFECT ON NEW MODIFIED RELEASE TABLET OF PF-06650833 IN HEALTHY SUBJECTS
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
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Other
- 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 female subjects of nonchild bearing 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 lb).
排除标准
- •Subjects with any of the following characteristics/conditions will not be included in the study:
- •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).
- •A positive urine drug test.
- •History of regular alcohol consumption within 6 months before screening.
- •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 BP greater than equal to 140 mm Hg (systolic) or more than equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
- •Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential;
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
- •History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON-TB Gold test.
- •History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
- •Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality
研究组 & 干预措施
Relative Bioavailability Cohort
Other
Relative Bioavailability cohort
干预措施: PF-06650833 (Drug)
结局指标
主要结局
Cmax
时间窗: 0-96 hours
AUClast
时间窗: 0-96 hours
次要结局
- Cmax under high fat meal fed conditions(0-96 hours)
- Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)(0-96 hours)
- AUClast under high fat meal fed conditions(0-96 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult VolunteersHealthyNCT06122194Pfizer12
已完成
1 期
A Phase I Trial to Investigate the Safety and Tolerability of PF-06649751HealthyNCT01981694Pfizer18
已完成
1 期
Food Effect Study of CTP-656 in Healthy Male VolunteersHealthyNCT02680249Concert Pharmaceuticals15
已完成
1 期
A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed StateHealthyNCT01706796Pfizer12
已完成
1 期
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562HealthyNCT01914796Pfizer39