NCT02094521已完成1 期
Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Area under the NNC0113-0987 plasma concentration time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for GLP-1 analogue NNC0113-0987 when administered orally in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male aged 18 between 55 years (both inclusive) at the time of signing informed consent
- •Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
- •Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive)
排除标准
- •History of, or presence of, cancer, diabetes or any clinically significant cardiovascular,respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- •Blood pressure above 140 mmHg systolic and/or above 90 mmHg diastolic or pulse above 90 beats per minute at the screening visit
- •Smoking more than 5 cigarettes or the equivalent per day (including use of nicotine substitute products)
- •History of significant drug abuse, or a positive drug test at the screening visit
- •Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit
研究组 & 干预措施
NNC0113-0987
Experimental
干预措施: NNC0113-0987 (Drug)
结局指标
主要结局
Area under the NNC0113-0987 plasma concentration time curve
时间窗: From time 0 to 24 hours after the 10th dosing
次要结局
- Maximum observed NNC0113-0987 plasma concentration(0 to 24 hours after the 10th dosing)
研究者
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