A PHASE 1, OPEN-LABEL, PARALLEL-GROUP, SINGLE-DOSE STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF [14C]-PF-07220060 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07220060 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
- 12
- 试验地点
- 1
- 主要终点
- Percentage of Total Radiocarbon (14C) Excreted in Urine
研究概览
简要总结
The purpose of this study is to learn about how much PF-07220060 will be taken up and processed by healthy male participants.
The study is seeking for participants who:
- are males aged 18 to 65 years and are healthy.
- have Body mass index (BMI) between 17.5 and 30.5 kilograms/meter2
- have a total body weight of at least 50 kilograms.
The study consists of two groups. In group 1, participants will take one amount of PF-07220060 by mouth. In group 2, participants will take one amount by mouth and one amount as an injection through a vein at the study clinic.
In group 1, participants will stay at the clinic site for up to 15 days. In group 2, the duration of participants' stay depends on the results of group 1.
During their stays, participants will have their blood, urine, and feces collected by the study doctors several times. We will measure the level of PF-07220060 in participants' blood, urine, and feces samples. This will help to know how much the study medicine is getting taken up by the body. At the end of the study, participants will be contacted by phone to check in. Participants will be involved in this study for about 9 weeks from the screening until the follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Key Eligibility criteria for this study include, but are not limited to the following:
- •Inclusion Criteria:
- •Male participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- •Body mass index (BMI) of 17.5-30.5 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
- •Participants with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome [IBS] or lactose intolerance).
- •Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of study intervention used in this study. Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
- •Total 14C radioactivity measured in plasma exceeding 11 mBq/mL.
研究组 & 干预措施
Cohort 1
Participants will receive one dose of [14C] PF-07220060 by mouth
干预措施: Oral [14C]PF-07220060 (Drug)
Cohort 2
Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060.
干预措施: Oral PF-07220060 (Drug)
Cohort 2
Participants will take one dose of PF-07220060 by mouth and one dose as an IV (intravenous) infusion of [14C] PF-07220060.
干预措施: IV [14C] PF-07220060 (Drug)
结局指标
主要结局
Percentage of Total Radiocarbon (14C) Excreted in Urine
时间窗: From Predose up to 14 days post-dose
Percentage of 14C excreted in urine following 14C PF-07220060 dose administration was determined as: (total 14C urine/ 14C dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
Percentage of Total Radiocarbon (14C) Excreted in Feces: Cohort 1
时间窗: From Predose up to 14 days post-dose
Percentage of 14C excreted in feces following 14C PF-07220060 oral dose administration was determined as: (total 14C feces/ 14C oral dose administered)\*100 where, 14C dose was administered dose of 14C PF-07220060.
Cumulative Percent Recovery of Total Radiocarbon (14C)
时间窗: From Predose up to 14 days post-dose
Percentage recovery of total radioactivity (14C ) in urine and feces was determined based on total administered dose.
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07220060: Cohort 1
时间窗: From Predose up to 96 hours post-dose
The percentage of five major metabolites detected in plasma after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by liquid chromatography mass spectrometry- accelerator mass spectrometry (LC-MS-AMS). For calculation of metabolite percentage of total plasma radioactivity (RA), first composite time-normalized human plasma pools were prepared for each participant from plasma samples collected from 0-96 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07220060: Cohort 1
时间窗: From Predose up to 144 hours post-dose
The percentage of five major metabolites detected in urine after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human urine pools were prepared for each participant from urine samples collected from 0-144 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07220060: Cohort 1
时间窗: From Predose up to 196 hours post-dose
The percentage of five major metabolites detected in feces after oral administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
Percentage of Metabolite Detected in Feces After IV Administration of PF-07220060: Cohort 2
时间窗: From Predose up to 196 hours post-dose
The percentage of five major metabolites detected in feces after IV administration of PF-07220060: 480a, 480b, 496a, M3 and 496b are reported in this outcome measure. The processed samples were analyzed by LC-MS-AMS. For calculation of percentage of metabolites, first composite time-normalized human fecal homogenate pools were prepared for each participant from fecal samples collected from 0-196 hours post-dose (i.e., a hamilton pool). Next, a multi-subject pool was created by combining equal volumes of each of the above individual participant pools. Results presented here are the single value output from these individual pooled multi-subject time-normalized samples.
次要结局
- Absolute Oral Bioavailability for Plasma Dose-Normalized Area Under the Curve (AUC)Infinity: Cohort 2(From Predose up to 14 days post-dose)
- Cohort 1 and 2: Fraction of PF-07220060 Dose Absorbed (Fa)(From Predose up to 14 days post-dose)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Baseline up to 35 days after the last dose of study intervention (up to Day 36))
- Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters(Baseline up to 35 days after the last dose of study intervention (up to Day 36))
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Baseline up to 35 days after the last dose of study intervention (up to Day 36))
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to 35 days after the last dose of study intervention (up to Day 36))