NCT07015918已完成1 期
A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07976016 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07976016 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH
干预措施
相关药物
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
- 1
- 主要终点
- Total recovery of radioactivity 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 about how much the study medicine PF-07976016 will be taken up and processed by healthy male participants. The total number of weeks of the study is up to approximately 12 weeks.
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
- •Males, 18 to 65 years of age
- •BMI 17.5 to 32 kg/m2 and a total body weight >50 kg (110 lb)
- •Willing and able to comply with all study procedures
排除标准
- •History of irregular bowel movements or lactose intolerance
- •Any medical or psychiatric condition or laboratory abnormality or other condition that may increase the risk of study participation
- •Use of any prohibited or concomitant medication(s)
- •Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
- •Positive urine drug test
- •History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
- •Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day
- •Previous administration of an investigational product within 30 days preceding the first dose of study medicine in this study.
研究组 & 干预措施
Arm 1
Experimental
Participants will receive doses of PF-07976016 with and without radiolabel.
干预措施: [14C] PF-07976016 (Drug)
Arm 1
Experimental
Participants will receive doses of PF-07976016 with and without radiolabel.
干预措施: PF-07976016 (Drug)
结局指标
主要结局
Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.
时间窗: From dose (Day 1) and for up to 21 days thereafter
次要结局
- Number of participants with treatment emergent adverse events(First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks))
研究者
研究点 (1)
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