A PHASE 1, OPEN-LABEL, 2-ARM PARALLEL STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF PF-07054894 USING 2 14C-RADIOLABELED PF-07054894 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07054894 IN HEALTHY ADULT MALE PARTICIPANTS 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
- 10
- 试验地点
- 1
- 主要终点
- Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.
研究概览
简要总结
The purpose of this study is to learn how quickly and to what extent the study medicine (PF-07054894) is absorbed, broken down, and eliminated from the body.
详细描述
There are two groups in this study:
- Cohort 1 (which has 2 periods)
- Cohort 2 (has 1 period) Participants will only have to participate in one of the 2 Cohorts.
- In Cohort 1 - Period 1, the study will check how the study medicine (PF-07054894) is removed from the body. In Period 2, the study will find out how well the study medicine is absorbed by the body when given by mouth compared to an intravenous route. (solution of the study medicine is injected directly into a vein). For this period, the PF-07054894 that is injected into the vein is radioactively labeled, but the dose given by mouth is not radioactively labeled. Radioactively labelled are compounds where one or more atoms have been replaced with a radioactive element. This allows researchers to track their movement within cells.
- In Cohort 2 - a different radioactive labelled material is used than the one of Cohort 1. This is done to see how PF 07054894 is removed from the body. The study will also look at how safe the study medicine is and how well it is tolerated when it is given to healthy people.
Participants in Cohort 1 will be involved in this study for about 10 weeks and about 8 weeks for those in Cohort 2. Participants in Cohort 1 will stay in the study clinic in Period 1 for up to 15 days (14 nights) and 8 days (7 nights) in Period 2. Participants in Cohort 2 will stay in the study clinic for up to 15 days (14 nights).
For Period 1 of both Cohort 1 and 2, the study doctor will be checking the levels of radioactively labeled study medicine in body frequently from Day 7 onwards in urine, stool, and any vomit and will let participants know as soon as possible if they have to stay longer or if they can go home. The duration of participants' stay will depend on how quickly or slowly the radioactively labeled study compound leaves their body.
For Period 2, participants will have to stay in the study clinic for 8 days (7 nights) and leave the study clinic on Day 7. However, if the study doctor believes it is necessary to protect participant's health, they may be asked to remain in the study clinic after Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 Period 1 and Period 2
Period 1: This is designed to evaluate the metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of [cyclobutenyl-14C]PF-07054894. In order to assess the metabolic fate of [14C]PF-07054894, metabolites of [14C]PF-07054894 circulating in plasma and eliminated in urine and feces following oral administration.
Period 2: This is designed to evaluate oral bioavailability of a drug and also allow to estimate the fraction of the dose absorbed of the oral PF-07054894 dose. Determination of the fraction of the dose absorbed will provide information on the total PF-07054894 dose absorbed, regardless of the fate of that dose after absorption (eg, metabolism, degradation).
干预措施: PF-07054894 (Drug)
Cohort 2 Period 1
This is designed to further evaluate the cleavage of PF-07054894, which was identified in plasma samples from a preliminary investigation of metabolism in the FIH study. The metabolic fate and extent of excretion of PF-07054894 following the study drug administration via the intended clinical route of administration (oral) of - [methyl-14C]PF-07054894 will be evaluated.
干预措施: PF-07054894 (Drug)
结局指标
主要结局
Cumulative recovery (%) of radioactivity in urine and feces (adjusted for vomitus, if any), expressed as a percent of total oral radioactive dose administered.
时间窗: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
To characterize the rate and extent of excretion of total radioactivity following administration of a single oral dose of \[14C\]PF-07054894(Period 1 of Cohort 1 \& 2).
Metabolite identification/profiling in feces, plasma and urine
时间窗: Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14
次要结局
- Cumulative recovery (%) of radioactivity in plasma expressed as a percent of total oral radioactive dose administered.(Period 1 of Cohort 1 & 2 pre-dose to maximum Day 14)
- Dose normalized AUCinf of intravenous radiolabeled PF-07054894 in plasma (if data permit).(Period 2 Cohort 1 pre-dose to maximum Day 7)
- The fraction of PF-07054894 dose absorbed (Fa).(Period 2 Cohort 1 pre-dose to maximum Day 7)
- The absolute oral bioavailability (F) of PF-07054894.(Period 1 of Cohort 1 pre-dose to maximum Day 14 and Period 2 Cohort 1 pre-dose to maximum Day 7)
- Number of participants with treatment emergent clinically significant laboratory abnormalities(From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2)
- Number of participants with treatment emergent clinically significant abnormal ECG measurements(From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2)
- Number of participants with treatment emergent clinically significant abnormal vital measurements(From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(From pre-dose to 28 days post-dose for Cohort 1 and Cohort 2)
- Maximum Observed Plasma Concentration (Cmax) of PF-07054894(Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose)
- Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) of PF-07054894(Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07054894(Day 1 pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240-, 264-, 288- and 312-hours post-dose)