A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497
研究概览
简要总结
The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.
The study is seeking for male and female participants who:
- Are 18 years of age or more.
- Are confirmed to be healthy after performing some medical and physical tests.
- Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.
The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period.
Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.
How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants.
In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.
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
盲法说明
Open-label Study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants ≥18 years of age, inclusive, at screening.
- •Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- •BMI of ≥17.5 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) or prior allergic reaction to any component of PF-
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the 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.
- •Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
研究组 & 干预措施
Part 1: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment A (Drug)
Part 1: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment B (Drug)
Part 1: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment C (Drug)
Part 1: PF-06821497 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment A (Drug)
Part 1: PF-06821497 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment B (Drug)
Part 1: PF-06821497 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment A
- Drug: Single dose of PF-06821497 Treatment B
- Drug: Single dose of PF-06821497 Treatment C
干预措施: PF-06821497 Treatment C (Drug)
Part 2: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment D
- Drug: Single dose of PF-06821497 Treatment E
- Drug: Single dose of PF-06821497 Treatment F
干预措施: PF-06821497 Treatment D (Drug)
Part 2: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment D
- Drug: Single dose of PF-06821497 Treatment E
- Drug: Single dose of PF-06821497 Treatment F
干预措施: PF-06821497 Treatment E (Drug)
Part 2: PF-06821497 Sequence 1
Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth.
Interventions:
- Drug: Single dose of PF-06821497 Treatment D
- Drug: Single dose of PF-06821497 Treatment E
- Drug: Single dose of PF-06821497 Treatment F
干预措施: PF-06821497 Treatment F (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497
时间窗: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Maximum Plasma Concentration (Cmax) for PF-06821497.
时间窗: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
The Cmax was observed directly from data.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs).(From screening up to Day 35)
- Number of Participants With Laboratory Abnormalities(From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.)
- Number of Participants With Clinically Significant ECG Findings(From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.)