A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, 2 SEQUENCE, 2 PERIOD CROSSOVER STUDY TO EVALUATE THE EFFECT OF HIGH-FAT MEAL ON THE RELATIVE BIOAVAILABILITY OF PF-07321332 BOOSTED WITH RITONAVIR 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
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
研究概览
简要总结
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.
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 —（Adult, Older 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 medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. Female participants of childbearing potential must have a negative pregnancy test.
- •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
- •Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of Screening or Day -
- •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).
- •Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy- or brady brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure, underlying structural heart disease, Wolff Parkinson-White syndrome).
- •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), 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.
研究组 & 干预措施
Treatment A
Single oral dose of ritonavir at -12 hours prior to PF-07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing.
干预措施: PF-07321332/ritonavir (Drug)
Treatment A
Single oral dose of ritonavir at -12 hours prior to PF-07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing.
干预措施: Ritonavir (Drug)
Treatment B
Single oral dose of ritonavir at -12 hours prior to PF 07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing.
干预措施: PF-07321332/ritonavir (Drug)
Treatment B
Single oral dose of ritonavir at -12 hours prior to PF 07321332/ritonavir dosing, followed by single oral dose of PF-07321332/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours PF-07321332 dosing.
干预措施: Ritonavir (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration was determined by linear/log trapezoidal method and reported in this outcome measure.
Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
AUCinf was calculated by AUClast + (Clast/kel). AUClast was the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). 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-07321332
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
Cmax was defined as maximum observed plasma concentration. It was observed directly from data.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days))
- Number of Participants With Clinical Laboratory Abnormalities(Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days))
- Number of Participants Meeting Pre-Specified Criteria for Vital Signs(Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days))
- Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values(Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2)
- Apparent Clearance (CL/F) of PF-07321332 From Plasma(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2)
- Apparent Volume of Distribution (Vz/F) of PF-07321332(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2)
- Terminal Elimination Half-life (t1/2) of PF-07321332(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2)