NCT01272973已完成1 期
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue 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
- 96
- 主要终点
- Frequency of adverse events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the 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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male subjects, based on an assessment of medical history, physical examination and
- •BMI between 21 and 30 kg/m2 (21 inclusive)
排除标准
- •Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
- •Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
- •The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
研究组 & 干预措施
Oral 1
Experimental
干预措施: semaglutide (Drug)
Oral 1
Experimental
干预措施: placebo (Drug)
Oral 2
Experimental
干预措施: semaglutide (Drug)
Oral 2
Experimental
干预措施: placebo (Drug)
Oral 3
Experimental
干预措施: semaglutide (Drug)
Oral 3
Experimental
干预措施: placebo (Drug)
S.c.
Active Comparator
干预措施: semaglutide (Drug)
结局指标
主要结局
Frequency of adverse events (AEs)
时间窗: from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose
次要结局
- Terminal phase elimination half-life(from last dose (day 70) to follow-up visit 91-105 days after first dose)
- Laboratory safety variables (haematology, biochemistry, and urinalysis)(from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose)
- Maximum plasma concentration of NN9924(after dosing on the 68th, 69th and 70th Day)
- Hypoglycaemic episodes(from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose)
- Area under the plasma concentration curve over the dosing interval (0-24 hours)(after dosing on the 68th, 69th and 70th day)
研究者
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