A PHASE 1, RANDOMIZED, OPEN-LABEL, 4-PERIOD, 5-TREATMENT, 6-SEQUENCE, CROSSOVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE BIOAVAILABILITY OF PF-07104091
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
研究概览
简要总结
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs.
- •Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of >50 kg (110 lb).
- •Written evidence of a personally signed and dated informed consent document (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).
- •Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- •History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
- •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 (eg, contact with positive case, residence, or travel to an area with high incidence) 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.
- •A positive urine drug test.
- •History of sensitivity to heparin or heparin induced thrombocytopenia.
研究组 & 干预措施
PF-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 1
Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation D (Treatment D) (Drug)
PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 2
Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation D (Treatment D) (Drug)
PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 3
Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation D (Treatment D) (Drug)
PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 4
Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment E) (Drug)
PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 5
Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment E) (Drug)
PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation A (Treatment A) (Drug)
PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation B (Treatment B) (Drug)
PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment C) (Drug)
PF-07104091 Sequence 6
Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth.
干预措施: Single dose of PF-07104091 as Tablet Formulation C (Treatment E) (Drug)
结局指标
主要结局
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
时间窗: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C
时间窗: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Cmax was maximum observed concentration. Cmax was observed directly from data.
次要结局
- AUCinf of PF-07104091 for Treatment C, D and E(Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)
- Cmax of PF-07104091 for Treatment C, D and E(Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs(From start of study treatment until 35 days after last dose of study treatment (Up to Day 54))
- Number of Participants With Laboratory Test Abnormalities(From start of study treatment until 35 days after last dose of study treatment (Up to Day 54))
- Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments(From start of study treatment until 35 days after last dose of study treatment (Up to Day 54))
- Number of Participants With Clinically Meaningful Findings in Vital Signs(From start of study treatment until 35 days after last dose of study treatment (Up to Day 54))
- Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments(From start of study treatment until 35 days after last dose of study treatment (Up to Day 54))