NCT01597713已完成1 期
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 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
- 83
- 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 (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.
The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.
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
- •Body mass index 18-28 kg/m^2 (both inclusive)
- •Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Known or suspected hypersensitivity to trial products or related products
- •Previous participation in this trial. Participation is defined as randomised
- •Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
- •Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Part 2, cross-over
Experimental
干预措施: NNC 0148-0000-0362 (Drug)
Part 1, level 1-7 escalating doses
Experimental
干预措施: NNC 0148-0000-0362 (Drug)
Part 1, level 1-7 escalating doses
Experimental
干预措施: insulin glargine (Drug)
Part 1, level 1-7 escalating doses
Experimental
干预措施: placebo (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit
次要结局
- Area under the glucose infusion rate (GIR)-time curve (Trial part 1)(From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively)
- Area under the serum insulin concentration-time curve (Trial part 2)(From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively)
- Area under the serum insulin concentration-time curve (with Trial part 1)(From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively)
研究者
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