NL-OMON49451已完成不适用
A single-center, open-label study to investigate the absorption, distribution, metabolism and excretion (ADME) of HDM201 (Siremadlin) after a single oral dose of 25 mg [14C]HDM201 in healthy subjects - [14C]HDM201
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
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 males and/or females age 18 to 54 years included
- •Weighy at least 55 kg and no more than 120 kg
- •BMI 18.0 - 30 kg/m2
排除标准
- •Females of childbearing potential (WOCBP).
- •Exposure to radiation at a level of 0.1 to1.0 mSv over the past year, 1.1 to
- •2.0 mSv over the past 2 years, or 2.1 to 3.0 mSv over the past 3 years, etc.,
- •e.g., due to systemic administration of radioactive substances, or to external
- •irradiation (e.g., by x-rays) for diagnostic,
- •therapeutic, job-related, or research purposes.
- •Use of other investigational drugs within 5 half-lives, or within 6 months (in
- •case of therapeutics with expected long half-lives such as immunoglobulin G
- •antibodies), or within 30 days prior to dosing (for
- •small molecule drugs with daily dosing scheme), or longer if required
- •by local regulations.
- •Any surgical or medical condition which might significantly alter the ADME of
- •drugs, or which may jeopardize the subject in case of participation in the
- •Has absence of regular defecation pattern (subjects with a mean defecation
- •frequency of less than once per 2 days or chronic diarrhea).
- •Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV),
- •and/or human immunodeficiency virus (HIV).
- •Smokers (use of tobacco/nicotine products in the previous 3 months).
- •History or presence of clinically significant ECG abnormalities or a family
- •history or presence of prolonged QT-interval syndrome.
研究者
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