NL-OMON48245已完成不适用
An open-label, single-dose study to evaluate the excretion and metabolism of oral [14C]-ONO-5788, and absolute bioavailability of oral ONO-5788 in healthy adult male subjects - ONO-5788 absolute bioavailability and mass balance study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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. The subject is willing and able to provide written informed consent.
- •2. Male subjects aged 21 to 65 inclusive at the time of signing the informed consent form.
- •3. The subject is able to communicate with the Investigator and the site staff.
- •4. A subject is eligible to participate if he is not trying to father a child, is willing to use one of the contraception methods listed in Section 5.3 and agrees not to donate sperm, from Day 1 of the study until 90 days after dosing.
- •5. The subject has a body mass index of 18.5 to 30.0 kg/m2, inclusive at screening.
排除标准
- •1. The Investigator deems the subject unsuitable for the study as a result of the screening examinations.
- •2. The subject is an employee of the Sponsor or contract research organization.
- •3. The subject has, or has a history of, any significant disease or disorder that would increase the risk for the subject if they were enrolled in the study or would affect study procedures or outcomes such as:
- •a. Gallstones, cholangitis, and/or cholecystitis;
- •b. Pancreatitis;
- •c. Hypothyroidism;
- •d. Known diabetes mellitus type 1 or type 2;
- •e. Hypocalcaemia or hypokalaemia;
- •f. Hypoglycaemia or hyperglycaemia or fasting blood glucose outside normal local range;
- •g. Thrombocytopenia or other clinically significant haematologic abnormalities;
- •h. Inflammatory bowel disease, irritable bowel syndrome, or abdominal surgery (with the exception of appendectomy);
- •i. Known vitamin B12 deficiency.
- •4. The subject has a positive, pre-study, hepatitis B, hepatitis C or human immunodeficiency virus test.
- •5. The subject has clinically significant serum electrolyte (sodium, potassium, chloride, bicarbonate) abnormalities at screening or admission, in the estimation and clinical judgment of the Investigator or designee.
研究者
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