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-07799544 USING A 14C-MICROTRACER APPROACH
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 2
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-07799544 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests.
Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 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-07799544 by mouth.
Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 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-07799544 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 7 weeks, including evaluation at the start and follow-up period.
详细描述
Not Provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
None (Open-Label)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 18 to 55years 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 17.5-32 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-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2
干预措施: Oral [14C] PF-07799544 (Drug)
Cohort 1
Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2
干预措施: IV [14C] PF-07799544 (Drug)
Cohort 1
Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1. After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2
干预措施: Oral Unlabeled PF-07799544 (Drug)