NCT01690169已完成1 期
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 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
- 45
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 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, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
- •Body mass index (BMI) above or equal to 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 is 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 12 weeks following the last dose of trial medication
- •Participation in another trial within 90 days prior to screening
- •Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an 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 acute idiopathic or chronic pancreatitis
研究组 & 干预措施
NNC0113-0987
Experimental
干预措施: NNC0113-0987 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
次要结局
- AUC, the area under the NNC0113-0987 plasma concentration-time curve(From dosing visit to infinity)
- Number and severity of hypoglycaemic episodes(From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25))
- tmax, the time to maximum plasma concentration of NNC0113-0987(From dosing visit until last PK sampling visit (e.g. day 11))
- Cmax, the maximum plasma concentration of NNC0113-0987(From dosing visit until last PK sampling visit (e.g. day 11))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Trial Investigating the Safety of NNC 0113-0987 in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01405261Novo Nordisk A/S101
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy SubjectsHealthyDiabetesNCT01978613Novo Nordisk A/S100
已完成
1 期
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01866748Novo Nordisk A/S170
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 and Male Subjects With Type 2 DiabetesHealthyDiabetesDiabetes Mellitus, Type 2NCT01686945Novo Nordisk A/S107
已完成
1 期
Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT01272973Novo Nordisk A/S96