NCT01334034已完成1 期
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0123-0000-0338 in Healthy 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
- 70
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 subject
- •Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive)
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
- •Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician
研究组 & 干预措施
Dose levels 1-7
Experimental
干预措施: NNC 0123-0000-0338 (Drug)
Dose levels 1-7
Experimental
干预措施: placebo (Drug)
Dose levels 1-7
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
Number of adverse events
时间窗: from trial product administration and until completion of the dosing visit (Day 0 to Day 6)
次要结局
- Area under the serum insulin concentration-time curve(from 0 to 120 hours after a single dose)
- Area under the glucose infusion rate-time curve(from 0 to 24 hours after a single dose)
研究者
研究点 (1)
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