A Phase 0, Open-label, Candidate Selection Study Assessing the Pharmacokinetics of 3 Drug Candidates After a Single Intravenous, 14C-labelled Microdose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The apparent elimination half-life of each of the 3 study compounds and their active metabolite after a single iv dose of each of the 3 study compounds
研究概览
简要总结
People with type 2 diabetes have too much sugar in their blood and need treatment to control their sugar level. The 3 study compounds in this study are similar to an approved antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes. This approved antidiabetic medicine is generally safe and well tolerated. The study compounds are expected to have the same antidiabetic effect as the approved medicine. The purpose of this study is to investigate how quickly and to what extent each of the 3 study compounds are broken down in the body (this is called pharmacokinetics). The dose of each study compound will be very low (this is called a microdose), and will be labelled with a small amount of carbon-14. This is radioactive, and it makes it possible to track the study compound in the blood. The 3 study compounds in this study have not been given to humans before. The study will be performed in up to 18 healthy male volunteers. The study will consist of 3 groups of 6 volunteers each. Each participant will receive only one dose of study medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subject.
- •Sex : Male.
- •Age 18 to 54 years, inclusive, at the time of signing informed consent.
- •Body mass index (BMI) 18.0 to 30.0 kg/m^2, inclusive, at the time of signing informed consent .
排除标准
- •Known or suspected hypersensitivity to study product(s) or related products.
- •Any disorder that in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- •Glycosylated haemoglobin (HbA1c) equal to or above 6.5% (48 mmol/mol) at screening.
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma.
- •Subjects with a history of malignant neoplasms within the past 5 years prior to screening.
- •Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).
- •Participation in a study with a radiation burden of above 0.1 millisievert (mSv) in the period of 1 year prior to screening.
研究组 & 干预措施
Study compound 1
Up to 6 volunteers will receive one dose of study compound 1
干预措施: NNC0113-6861 (Drug)
Study compound 2
Up to 6 volunteers will receive one dose of study compound 2
干预措施: NNC0113-6860 (Drug)
Study compound 3
Up to 6 volunteers will receive one dose of study compound 3
干预措施: NNC0113-6891 (Drug)
结局指标
主要结局
The apparent elimination half-life of each of the 3 study compounds and their active metabolite after a single iv dose of each of the 3 study compounds
时间窗: From time of first dosing (Day 1) until Day 64
hours
次要结局
未报告次要终点