NCT01620476已完成1 期
A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (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
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma liraglutide curve
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 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
- •Any clinical laboratory values deviated from the reference range at the laboratory
- •Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- •History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders.
- •History of significant allergy or hypersensitivity
- •Known or suspected allergy to trial product or related products.
- •History of drug or alcohol abuse
- •Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure
研究组 & 干预措施
15 mcg/kg
Experimental
干预措施: placebo (Drug)
5 mcg/kg
Experimental
干预措施: liraglutide (Drug)
5 mcg/kg
Experimental
干预措施: placebo (Drug)
10 mcg/kg
Experimental
干预措施: liraglutide (Drug)
10 mcg/kg
Experimental
干预措施: placebo (Drug)
15 mcg/kg
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Area under the plasma liraglutide curve
次要结局
- Cmax, maximum plasma liraglutide concentration
- tmax, time to reach Cmax
- Terminal phase elimination rate-constant
- 24-hour profiles of serum glucose
- t½, terminal elimination half life
- 24-hour profiles of serum insulin
- 24-hour profiles of plasma glucagon
- Adverse events
研究者
研究点 (1)
Loading locations...
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