NCT01620463已完成1 期
A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese 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
- 32
- 试验地点
- 1
- 主要终点
- Vital signs (Blood pressure)
研究概览
简要总结
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese 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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18 and 27 kg/m^2, inclusive
排除标准
- •Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator
- •Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator
- •Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic
- •Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
- •Alcohol intake within 48 hours prior to the screening
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- •Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator
- •History of significant allergy or hypersensitivity
- •Known or suspected allergy to trial product or related products
- •History of drug or alcohol abuse
- •Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
研究组 & 干预措施
NNC 90-1170
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Vital signs (Blood pressure)
Body weight
Vital signs (Pulse rate)
ECG (ElectroCardioGram)
Adverse events
次要结局
- 24-hour glucose profile in serum
- Area under the plasma NNC 90-1170 curve
- Maximum plasma NNC 90-1170 concentration, Cmax
- Terminal elimination half-life, t1/2
- 24-hour insulin profile in serum
- 24-hour glucagon profile in plasma
- Time to maximum plasma NNC 90-1170 concentration, tmax
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 Japanese VolunteersHealthyDiabetesNCT01620476Novo Nordisk A/S24
已完成
1 期
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy VolunteersCongenital Bleeding DisorderHealthyNCT00822185Novo Nordisk A/S32
已完成
1 期
Safety and Tolerability of Liraglutide in Healthy Japanese Male VolunteersDiabetesDiabetes Mellitus, Type 2NCT01515592Novo Nordisk A/S24
已完成
1 期
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese VolunteersAcquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary BypassHealthyNCT01153997Novo Nordisk A/S24
已完成
1 期
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese SubjectsHealthyDiabetesNCT01868555Novo Nordisk A/S32