NL-OMON45995已完成不适用
A Phase 1, Open-Label, Non-Randomized, 2-Period, Fixed Sequence Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14c-Pf-06700841] and to Assess the Absolute Bioavailability and Fraction Absorbed of Pf-06700841 in Healthy Male Subjects using a 14C-Microtracer Approach - PF-06700841 ADME microtracer study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer, Inc.
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1.Healthy male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including BP and pulse rate (PR) measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.;2.Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).;3.Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.;4.Subjects who are willing and able to comply with study confinement period, scheduled visits, treatment plan, laboratory tests, contraceptive requirements and other study procedures.
排除标准
- •1.Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies).;2.Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).;3.Inability to have at least one bowel movement every 2 days on average.;4.A positive urine drug screen for drugs of abuse or recreational drugs.
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