Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide Lysine in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 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 the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of at least 60 kg
- •Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered generally healthy
排除标准
- •Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
- •Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
- •Prescription medicine and non-prescription medicine with few exceptions
- •Current and prior history of alcohol or drug abuse
- •Current smoking of more than 5 cigarettes per day
- •Mental incapacity, language barriers, or unwillingness to comply with the protocol
研究组 & 干预措施
Cohort 1a: Lira-depot 2.25 mg
干预措施: liraglutide-depot (Drug)
Cohort 2a: Lira-depot 6.75 mg
干预措施: liraglutide-depot (Drug)
Cohort 3a: Lira-depot 15 mg
干预措施: liraglutide-depot (Drug)
Cohort 4a: Lira-depot 30 mg
干预措施: liraglutide-depot (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs)
时间窗: Day 0 and up to 21 days after treatment
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.
次要结局
- Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot(Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose)
- Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity(Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose)
- Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment(1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose)
- Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot(Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose)
- Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment(0 to 168 hours after dosing)
- Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up(Day 0 and Day 21)