NCT07235137已完成1 期
A Phase 1, Single Arm Study to Evaluate the Pharmacokinetics Following Single Dose of PF-07817883 (Ibuzatrelvir) in Healthy Chinese Adult Participants.
干预措施
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
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
A study to learn how the study medicine called Ibuzatrelvir is taken up into the blood in healthy Chinese adults.
详细描述
To evaluate the PK profile of ibuzatrelvir after administration in Chinese healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 aged from 18 years old or older at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- •BMI of 16-32 kg/m2 (both inclusive); and a total body weight >45 kg (99 lbs.).
- •Chinese male and female participants are defined as individuals currently residing in mainland China who were born in China and have both parents of Chinese descent.
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 (e.g., 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 recent (within the past year) or active suicidal ideation/behavior 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 7 days or 5 half-lives (whichever is longer) 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.
- •Pregnant or breastfeeding women.
- •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.
- •Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (e.g., 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 bradyarrhythmia 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 a physician 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, Bilirubin ≥1.5× ULN
研究组 & 干预措施
Ibuzatrelvir
Experimental
Ibuzatrelvir will be given by mouth to adult Chinese healthy volunteers
干预措施: Ibuzatrelvir (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: up to Day 3
AUCinf
时间窗: up to Day 3
Terminal phase half-life (t½)
时间窗: up to Day 3
次要结局
- Adverse events and severe adverse events(up to Day 3)
- Incidence of abnormal and clinically relevant changes in vital signs(up to Day 3)
- Incidence of abnormal and clinically relevant changes in electrocardiogram(Up to Day 3)
- Incidence of abnormal and clinically relevant changes in laboratory assessments(Up to Day 3)
研究者
研究点 (1)
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