A PHASE 1, OPEN-LABEL, 4-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07328948 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07328948 IN HEALTHY MALE ADULT 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
- 8
- 试验地点
- 1
- 主要终点
- Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered.
研究概览
简要总结
The purpose of this study is to learn how a certain amount of [14C] PF-07320948 is taken up into the bloodstream and removed from the body.
This study is seeking participants who are:
- Male between 18 to 64 years of age
- Deemed to be healthy
This is a 2 Part, 4 Period study where Part 1 has Periods 1 and 2 and Part 2, which is optional, has Periods 3 and 4.
Part 1
- Period 1: The purpose is to see how much of the study medicine PF-07328948 gets into and leaves the body.
- Period 2: The goal is to compare how much PF-07328948 is available in the body when taken by mouth versus by injection into the blood.
Part 2 (Optional)
- Period 3 (optional): If needed, the purpose is to see how PF-07328948 acts after taking it daily until the body reaches a steady level.
- In Period 4 (optional), the goal is to check again how much PF-07328948 is absorbed and leaves the body after daily dosing.
During study clinic stays and study visits, the study team will collect urine and blood samples and perform safety reviews. If only Part 1 is conducted, total time in the study (screening (start) through follow-up (end)) will be about 14 weeks. If both Part 1 and Part 2 are conducted, total time in the study will be about 22 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged ≥18 years to <65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 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.
- •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.
- •Background radioactivity measured in plasma and/or urine at screening exceeding an F14C value of 2.
- •Prior participation in a radiolabeled ADME clinical study within 12 months prior to screening.
研究组 & 干预措施
Period 1/Treatment A
Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension.
干预措施: Oral [14C]PF-07328948 (Drug)
Period 2/Treatment B
Participants will receive a single tablet of unlabeled oral dose of PF-07328948; ~ 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948
干预措施: Oral Unlabeled PF-07328948 (Drug)
Period 2/Treatment B
Participants will receive a single tablet of unlabeled oral dose of PF-07328948; ~ 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948
干预措施: IV [14C]PF-07328948 (Drug)
Period 3/Treatment C
Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month
干预措施: Oral Unlabeled PF-07328948 (Drug)
Period 4/Treatment D
Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets
干预措施: Oral [14C]PF-07328948 (Drug)
结局指标
主要结局
Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered.
时间窗: Period 1 pre-dose to maximum Days 22
次要结局
- Number of Participants with Treatment Emergent Adverse Events(From baseline and through 28 to 35 days post last study intervention dose)