NL-OMON48152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-06651600 and to assess the absolute bioavailability and fraction absorbed of PF-06651600 in healthy male participants using a 14C-microtracer approach - PF-06651600 ADME microtracer study
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
- •- healthy male subjects
- •- 18-55 yrs, inclusive
- •- BMI: 18.0-30.0 kg/m2, inclusive
- •- total bodyweight > 50 kg
排除标准
- •1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, appendectomy).
- •3. Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.
- •4. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
- •a. For hepatitis B, all participants will undergo testing for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb). Participants who are HBsAg positive are not eligible for this study. Participants who are HBsAg negative but HBcAb positive will be reflex tested for hepatitis B surface antibody (HBsAb).
- •b. For hepatitis C, all participants will undergo testing for hepatitis C antibody (HCVAb) during Screening.
- •Participants who are HCVAb positive will be reflex tested for hepatitis C RNA (HCV RNA). Participants who are HCVAb and HCV RNA positive are not eligible for the study.
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