A PHASE 1, OPEN-LABEL, SINGLE-DOSE STUDY TO INVESTIGATE THE MASS BALANCE, METABOLISM AND EXCRETION OF [14C]PF-07321332 IN HEALTHY MALE PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Cumulative amount of radioactivity Recovered in Urine (Ae)
研究概览
简要总结
This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled [14C]PF-07321332 in healthy male participants following oral administration with ritonavir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), 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 >50 kg (110 lb).
- •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
- •Positive test result 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 arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than New York Heart Association (NYHA) 1, 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 B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
- •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.
- •Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
- •A positive urine drug test.
- •Participants enrolled in a previous radio-nucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry (ie, occupational exposure of 5 rems per year).
研究组 & 干预措施
[14C]PF-07321332
Single oral dose of 300 mg [14C]PF-07321332 containing approximately 100 µCi [14C]PF-07321332 coadministered with 100 mg ritonavir.
干预措施: [14C]PF-07321332 (Drug)
结局指标
主要结局
Cumulative amount of radioactivity Recovered in Urine (Ae)
时间窗: 0 to 240 hours
Ae is the cumulative amount of radioactivity recovered in urine. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Cumulative amount of radioactivity Recovered in Feces (Ae)
时间窗: 0 to 240 hours
Fe is the cumulative amount of radioactivity recovered in feces. Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval. Sample volume = (feces weight in gram \[g\]).
Metabolic Profiling in blood
时间窗: 0 to 24 hours
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in plasma if possible.
Metabolic Profiling in Urine
时间窗: 0 to 240 hours
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in urine if possible.
Metabolic Profiling in Feces
时间窗: 0 to 240 hours
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in feces if possible.
次要结局
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)(Baseline (Day 0) up to 28 days after last dose of study medication)
- Number of Participants With Notable Electrocardiogram (ECG) Values(From baseline up to 11 days.)
- Number of Participants With Clinically Notable Vital Signs(From baseline up to 11 days)
- Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade(From baseline up to 11 days)