ISRCTN37043682进行中（未招募）1 期
Open-label, non-randomized study investigating the excretion balance, pharmacokinetics, and metabolism of a single intravenous dose of [14C]-labelled RO7223280 in healthy male participants
Roche (United States)0 个研究点目标入组 10 人开始时间: 2022年7月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- 性别
- Male
入选标准
- •1. Able and willing to provide written informed consent and comply with the study protocol according to International Council for Harmonisation (ICH) and local regulations
- •2. Male participants aged 35 to 64 years old (inclusive) at screening
- •3. Healthy male participants. Health status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, clinical chemistry, serology, coagulation, and urinalysis.
- •4. Participants must weigh at least 50 kilograms (kg) and must have a body mass index (BMI) within the range of 18-32 kilograms per square meter (kg/m^2) (inclusive) at screening
排除标准
- •1. History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer, or cirrhosis
- •2. History or evidence of any medical condition potentially altering the absorption, distribution, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy and hernia repair)
- •3. History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PQ/PR interval >210 milliseconds (ms), QTcF >450 ms) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)
- •4. History of malignancy
- •5. Evidence of human immunodeficiency virus (HIV) infection and/or positive for human HIV antibodies
- •6. Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at screening or within 3 months prior to study drug administration
- •7. History of hypersensitivity to any of the excipients in the formulation of RO7223280
- •8. Infrequent bowel movements (less than once per 24 hours on average)
- •9. Regular work with ionizing radiation or radioactive material
- •10. Participants who plan to attempt to father children within 3 months after the study drug administration
- •11. Participants who have been exposed to ionizing radiations within one year prior to study drug administration
研究者
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