A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 4-PERIOD, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY AND EFFECT OF FOOD FOLLOWING ORAL ADMINISTRATION OF A NEW TABLET FORMULATION RELATIVE TO THE ORIGINAL FORMULATION OF IBUZATRELVIR 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
- 17
- 试验地点
- 1
- 主要终点
- Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
研究概览
简要总结
Healthy adults will be enrolled into this open-label, Phase 1 research study. Participants will spend about 9 nights and 10 days in the clinical research unit (CRU) and the total time in the study will be about 11 weeks.
The goal of this clinical trial is to compare how much of the study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food. The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. This study drug is taken by mouth.
详细描述
This is a Phase 1, open-label, randomized, 4-period, 6-sequence crossover study in healthy adult participants. The goal of this clinical study is to compare how much of the oral (taken by mouth) study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food (fasted). The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. Safety and tolerability after taking the study medication will also be assessed.
Healthy adult participants will be screened within 28 days prior to the first day of study treatment. Participants will take one dose of study drug on the first day of each of 4 dosing periods that are 2-3 days each. Participants will remain in the clinical research unit (CRU) from Day -1 of Period 1 until completion of procedures on Day 3 of Period 4. This means that participants will stay in the CRU for a total of 9 nights and 10 days. The follow-up phone call will take place approximately 28-35 days after the last dose of study drug. The total time in the study is about 10-11 weeks.
The study treatments are:
Treatment A: ibuzatrelvir (original) fasted Treatment B: ibuzatrelvir (new) fasted Treatment C: ibuzatrelvir (new as dispersion in water) fasted Treatment D: ibuzatrelvir (new) fed
This is a crossover study which means that the treatment groups will receive the same treatments (A, B, C, and D) in a different order during the 4 dosing 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
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
- •18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs.
- •BMI of 16-32 kg/m2; and a total body weight >45 kg.
- •Participants who are capable of giving signed informed consent and willing and able to comply with all scheduled visits, treatment plans, 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 HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions 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 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention with the exception of moderate or strong CYP3A inducers which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
- •Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
- •A positive urine drug test. A single repeat for positive drug screen may be allowed.
- •Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- •An eGFR <60 mL/min/1.73 m² as determined by the CKD-EPI equation using Screat.
- •Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (including, but not limited to, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST segment and/or T wave changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer interpreted ECGs with abnormal findings should be overread by an investigator experienced in reading ECGs before excluding a participant.
- •Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- •ALT, AST, T Bili >1.5× ULN.
- •History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
- •Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- •Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day.
- •History of sensitivity reactions to ibuzatrelvir or any of the formulation components of ibuzatrelvir.
研究组 & 干预措施
Treatment B
single dose of ibuzatrelvir new tablet formulation in the fasted state on Day 1 of the treatment period
干预措施: Ibuzatrelvir filmcoated tablet (Drug)
Treatment C
single dose of ibuzatrelvir of the new tablet formulation dispersed in water and given in the fasted state on Day 1 of the treatment period
干预措施: Ibuzatrelvir filmcoated tablet (Drug)
Treatment D
single dose of ibuzatrelvir new tablet formulation in the fed state on Day 1 of the treatment period
干预措施: Ibuzatrelvir filmcoated tablet (Drug)
Treatment A
single dose of ibuzatrelvir original tablet formulation in the fasted state on Day 1 of the treatment period
干预措施: Ibuzatrelvir co-process API film coated tablet (Drug)
结局指标
主要结局
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
时间窗: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
Plasma ibuzatrelvir Cmax in the fasted state
时间窗: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
次要结局
- Incidence of AEs, clinical laboratory measurements, vital signs, and standard 12-lead ECGs(Day 1-35)
- Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast)(Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period)
- Plasma ibuzatrelvir Cmax(Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period)