NCT01037582已完成1 期
Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 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
- 155
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events (AEs) recorded
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 and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male 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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects with good general health as judged by the Investigator
- •Body weight of 65.0-95.0 kg (both inclusive)
- •Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (both inclusive)
排除标准
- •Known or suspected allergy to trial product or related products
- •Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the Investigator
- •Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator
研究组 & 干预措施
Trial part 2
Experimental
干预措施: placebo (Drug)
Trial part 1
Experimental
干预措施: NN9924 (oral) (Drug)
Trial part 1
Experimental
干预措施: placebo (Drug)
Trial part 2
Experimental
干预措施: NN9924 (oral) (Drug)
Trial part 2
Experimental
干预措施: NN9924 (s.c.) (Drug)
Trial part 2
Experimental
干预措施: NN9924 (i.v.) (Drug)
结局指标
主要结局
Number and severity of adverse events (AEs) recorded
时间窗: from dosing to Day 22
次要结局
- The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound(from 0 to 504 hours)
研究者
研究点 (1)
Loading locations...
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