NCT03448172已完成1 期
A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects
适应症
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
- 6
- 试验地点
- 1
- 主要终点
- Mass Balance
研究概览
简要总结
The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages of 18 and 45 years, inclusive.
- •Body mass index (BMI) of >= 17.5 and <= 30.4 kg/m2
- •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, allergic disease or clinical findings.
研究组 & 干预措施
Investigational Product
Experimental
[14C]PF-05221304
干预措施: [14C]PF-05221304 (Drug)
结局指标
主要结局
Mass Balance
时间窗: 0-96 hr
Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered
次要结局
- Radioactivity Cmax(0-96 hr)
- Plasma PF-05221304 Tmax(0-96 hr)
- Radioactivity t1/2(0-96 hr)
- Number of subjects experiencing an adverse event(Up to 28 days post dosing of IP on Day 1)
- Metabolic profiling for PF-05221304 in plasma, urine, and feces(0-96 hr)
- Radioactivity AUClast(0-96 hr)
- Plasma PF-05221304 Cmax(0-96 hr)
- Radioactivity Tmax(0-96 hr)
- Plasma PF-05221304 AUClast(0-96 hr)
- Radioactivity AUCinf(0-96 hr)
- Plasma PF-05221304 AUCinf(0-96 hr)
- Plasma PF-05221304 t1/2(0-96 hr)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male VolunteersHealthyNCT01147549AstraZeneca4
已完成
1 期
A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male ParticipantsHealthy VolunteersNCT05284890Bristol-Myers Squibb8
已完成
1 期
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male VolunteersHealthyNCT01058447AstraZeneca4
已完成
1 期
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male SubjectsHealthy VolunteerNCT01474668Genentech, Inc.5
已完成
1 期
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0980 Following Single Oral Dose Administration in Healthy Postmenopausal Female SubjectsHealthy VolunteerNCT01487239Genentech, Inc.4