A Phase 1, Open-label, Fixed Sequence, 2-period Study in Healthy Adult Male Participants to Assess the Mass Balance, Absolute Bioavailability, Fraction Absorbed, and Pharmacokinetics of [ 14C]PF-07104091
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Percentage of Total Radiocarbon (14c) excreted in feces
研究概览
简要总结
The purpose of this study is to learn how the body processes the study medicine PF-07104091.
The study is seeking participants who are:
- Healthy male aged 18 to 65 years of age
Participants in the study will receive 14C-labeled PF-07104091 by mouth after a meal. After 14 days, the participants will receive PF-07104091 by mouth (after a meal) followed by IV fusion (given directly into a vein) of microdose [14C]PF-07104091.
The study will help understand how the body processes study medicine PF-07104091 and how the medicine is changed and removed from the body after you take it. This study will also help to understand how much PF-07104901 is taken up into the blood.
Participants will remain in the study clinic for a maximum of 23 days and will have one follow-up contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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
Regimen A; Period 1
Single oral dose of 14C-labeled PF-07104091 administered under fed conditions.
干预措施: PF-07104091 (Drug)
Regimen B; Period 2
Single oral dose of unlabeled PF-07104091 administered under fed conditions followed by an intravenous (IV) infusion of PF-07104091 containing a microdose of 14C-labeled PF-07104091.
干预措施: PF-07104091 (Drug)
结局指标
主要结局
Percentage of Total Radiocarbon (14c) excreted in feces
时间窗: From Predose up to 14 days post dose of period 1 (and if applicable for Period 2)
Percentage of 14C excreted in feces following 14C PF-07104091 single dose administration will be determined as: (Total 14C feces/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of Total Radiocarbon (14c) excreted in vomitus (if applicable)
时间窗: From Predose up to 14 days post dose of period 1 only
Percentage of 14C excreted in vomitus (if applicable) following 14C PF-07104091 single dose administration will be determined as: (Total 14C vomitus/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Cumulative Percent Recovery of Total Radiocarbon (14C)
时间窗: From Predose up to 14 days post dose of period 1 only
Percentage recovery of total radioactivity (14C) in urine, feces, and vomitus (If applicable) was determined based on total administered dose.
Percentage of Metabolite Detected in Feces After Oral Administration of PF-07104091
时间窗: From Predose to 14 days post dose of period 1
The percentage of major metabolites detected in feces after oral administration of PF-07104091
Percentage of Total Radiocarbon (14c) excreted in urine
时间窗: From Predose up to 14 days post dose of period 1 and 2
Percentage of 14C excreted in urine following 14C PF-07104091 single dose administration will be determined as: (Total 14C urine/ 14C dose administered) \*100 where, 14C dose was administered dose of 14C PF-07104091.
Percentage of Metabolite Detected in Plasma After Oral Administration of PF-07104091
时间窗: From Predose to 14 days post dose of period 1
The percentage of major metabolites detected in plasma after oral administration of PF-07104091
Percentage of Metabolite Detected in Urine After Oral Administration of PF-07104091
时间窗: From Predose to 14 days post dose of period 1
The percentage of major metabolites detected in urine after oral administration of PF-07104091
次要结局
- Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters(From baseline up to 35 days after the last dose of study intervention (up to Day 36))
- Oral Absolute Bioavailability(From Predose up to 14 days post dose, period 2 only.)
- Fraction of PF-07104091 Dose Absorbed (Fa)(From Predose up to 14 days post dose)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From 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(From 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(From baseline up to 35 days after the last dose of study intervention (up to Day 36))