A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE ATIRMOCICLIB (PF-07220060) HIGHER DRUG LOAD IR MST TABLETS AND ATIRMOCICLIB IR MST TABLETS ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf)
研究概览
简要总结
The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market.
The study is seeking participants who are:
- Healthy males and females aged 18 to 65 years
- Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
- Body Mass Index of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (kg) [110 pounds (lb)].
Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin).
The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- •BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- •Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
- •Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
排除标准
- •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).
- •A positive urine drug test
- •Unwilling or unable to comply with the Lifestyle Considerations criteria of this study
- •Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
研究组 & 干预措施
Regimen B; Treatment Sequence B
Single Oral Dose of test tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of reference tablet formulation PF-07220060
干预措施: PF-07220060 (Drug)
Regimen A; Treatment Sequence A
Single Oral Dose of reference tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of test tablet formulation PF-07220060
干预措施: PF-07220060 (Drug)
结局指标
主要结局
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf)
时间窗: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (If data does not permit reporting of AUCinf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Area under the Plasma Concentration-Time profile (AUC) from time 0 extrapolated to extrapolated infinite time (AUCinf) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data permits).
时间窗: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits). It is obtained from AUC (0-t) plus AUC (t-inf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Maximum Observed Plasma Concentration (Cmax) profile of test and reference atirmociclib formulations after a high fat/high calorie meal
时间窗: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
次要结局
- Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters(From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2))
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)(From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2))
- Number of Participants with Clinically Significant Abnormalities in Vital Signs(From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2))
- Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities(From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2))