A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE,ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07248144 USING A 14C-MICROTRACER APPROACH
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Total recovery of radioactivity in urine, feces and vomitus (if any) expressed as a percent of total radioactive dose administered.
研究概览
简要总结
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study.
The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07248144 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
- females who cannot have children, or males
- 18 years of age or older
- confirmed to be healthy based on medical and physical tests.
- weigh more than 50 kilograms (kg) and have a body mass index of 18 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07248144 by mouth. Part two will begin at least 28 days after the dose in part one. In part two, participants will receive one full dose of PF-07248144 by mouth and one small dose of [14C] PF-07248144 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand:
- How much PF-07248144 is taken up into the bloodstream when taken by mouth compared to the dose given by IV
- How the body removes it from the blood steam.
Participants will take part in the study for about 15 weeks, including evaluation at the start and follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Female of nonchildbearing potential or male ≥18 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs.
- •BMI of 18-32 kg/m2; and a total body weight >50 kg (110 lb).
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.
- •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.
- •Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
研究组 & 干预措施
Cohort 1
Participants will receive one dose of [14C] PF-07248144 by mouth in Period 1. After a washout, participants will receive one dose of PF-07248144 by mouth and one intravenous (IV) infusion of [14C] PF-07248144 in Period 2
干预措施: Oral [14C] PF-07248144 (Drug)
Cohort 1
Participants will receive one dose of [14C] PF-07248144 by mouth in Period 1. After a washout, participants will receive one dose of PF-07248144 by mouth and one intravenous (IV) infusion of [14C] PF-07248144 in Period 2
干预措施: Oral unlabeled PF-07248144 (Drug)
Cohort 1
Participants will receive one dose of [14C] PF-07248144 by mouth in Period 1. After a washout, participants will receive one dose of PF-07248144 by mouth and one intravenous (IV) infusion of [14C] PF-07248144 in Period 2
干预措施: IV [14C] PF-07248144 (Drug)
结局指标
主要结局
Total recovery of radioactivity in urine, feces and vomitus (if any) expressed as a percent of total radioactive dose administered.
时间窗: Period 1 pre-dose to maximum Days 22
To characterize the extent of excretion of total radioactivity in urine, feces, and vomitus (if any) following administration of a single oral dose of \[14C\]PF-07248144.
Metabolic profiling/identification and determination of relative abundance of [14C]PF-07248144 and the metabolites of [14C]PF-07248144 in plasma, urine, and feces.
时间窗: Period 1 pre-dose to maximum Days 22
To characterize the metabolic profile and identify circulating and excreted metabolites following administration of a single oral dose of \[14C\]PF-07248144.
次要结局
- The ratio of dose-normalized plasma AUCinf (if data permit, otherwise AUClast) of oral unlabeled PF-07248144 and IV microtracer of [14C]PF-07248144 in Period 2 only.(Period 2 pre-dose to maximum Days 10)
- The ratio of total urinary radioactivity following oral administration of [14C]PF-07248144 in Period 1 and IV microtracer, microdose administration of [14C]PF-07248144 in Period 2.(Period 1 pre-dose to maximum Days 22; Period 2 pre-dose to maximum Days 10)
- Number of Participants With Treatment Emergent Adverse Events(Baseline and through 28 to 35 days post last study intervention dose)
- Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities(From Baseline up to 28 to 35 days post last study intervention dose)
- Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs(From Baseline up to 28 to 35 days post last study intervention dose)
- Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities(From Baseline up to 28 to 35 days post last study intervention dose)
- Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements(From Baseline up to 28 to 35 days post last study intervention dose)