NCT01507272已完成1 期
A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- AUC (area under the curve)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects of any ethnic origin
- •Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
- •Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
- •Body mass index within the range 20-27 kg/m^2, inclusive
排除标准
- •Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
- •History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
- •Alcohol intake within 48 hours of visit
- •Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
- •History of significant drug allergy or drug hypersensitivity
- •Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
- •Subjects who drink more than 8 cups of tea/coffee per day
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
NNC 90-1170 (liraglutide)
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
AUC (area under the curve)
次要结局
- Cmax, maximum concentration
- tmax, time to maximum concentration
- t½, terminal half-life
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 DiabetesHealthyDiabetesDiabetes Mellitus, Type 2NCT01507285Novo Nordisk A/S24
已完成
1 期
Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male SubjectsHealthyDiabetesDiabetes Mellitus, Type 2NCT03144271Novo Nordisk A/S58
已完成
1 期
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®Growth Hormone DisorderHealthyNCT01034202Novo Nordisk A/S56
已完成
1 期
Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Characteristics of Explorative Formulations of Insulin Degludec and IDegAsp 50 in Healthy Japanese SubjectsHealthyDiabetesNCT01865331Novo Nordisk A/S32
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Explorative Formulation of Insulin DegludecDiabetesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2NCT01865279Novo Nordisk A/S64