NCT01405261已完成1 期
Investigation on Safety, Tolerability, and Pharmacokinetics of Single 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
- 101
- 主要终点
- Overview of Treatment Emergent Adverse Events (AEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 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
- 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
- 否
入选标准
- •Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood and urinary laboratory assessments at the screening visit
- •Body Mass Index (BMI) of minimum 18.5 and below 30 kg/m^2
排除标准
- •Male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
- •The receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial
- •Subjects with a 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 that might have impact on the current trial, as judged by the investigator
- •Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
- •History of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (UNR)
研究组 & 干预措施
NNC 0113-0987 (gastro)
Experimental
干预措施: oral placebo (Drug)
NNC 0113-0987 (gastro)
Experimental
干预措施: oral NNC 0113-0987 (Drug)
NNC 0113-987 (coated)
Experimental
干预措施: oral NNC 0113-0987 (Drug)
NNC 0113-987 (coated)
Experimental
干预措施: oral placebo (Drug)
NNC 0113-987 (i.v)
Experimental
干预措施: I.v. NNC 0113-0987 (Drug)
结局指标
主要结局
Overview of Treatment Emergent Adverse Events (AEs)
时间窗: Up to 25 days after trial product administration
次要结局
- Frequency of hypoglycaemic episodes(From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration))
- The time to maximum concentration (tmax) of NNC 0113-0987 in plasma(After a single oral dose)
- AUC0-240h; area under the NNC 0113-0987 concentration-time curve(From time 0 to 240 hours after a single oral or intravenous (i.v.) dose)
- AUC, area under the curve(From time 0 to infinity after a single oral or i.v. dose)
- Cmax; maximum concentration of NNC 0113-0987 in plasma(After a single oral or i.v. dose)
研究者
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