An Open-label, Randomized, Single Center, Crossover Study in Healthy Participants to Assess Lipoprotein Lipase Activity and Levels, and Triglyceride Levels After Heparin Exposure, in Both Fasted and Postprandial State
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state
研究概览
简要总结
In this study biomarkers in the blood after exposure to heparin in the fasted state or after a high-fat meal will be investigated. Heparin will be administered as an intravenous (iv) injection (injection directly in a blood vessel). In this study, the effects of administration of heparin will be compared with the effects of administration of normal saline which will also be administered as an iv injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject
- •Male or female
- •18 to 65 years, inclusive, at the time of signing informed consent
- •Body mass index:18.0 kg/m ^2 to 29.9 kg/m^2, inclusive, at the time of signing informed consent
- •Body weight greater than or equal to 50 kg at the time of signing informed consent
- •Exclusion criteria:
- •Using tobacco products within 60 days prior to the first drug administration.
- •Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
- •History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).
- •Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.
- •Participation in any clinical study of an approved or non-approved investigational medicinal product within 30 days (or 5 half-lives of the investigational medicinal product, whichever is greater) before screening. If the half-life of the investigational medicinal product is unknown, subjects participating in a clinical trial in the 6 months prior to (the first) treatment administration will be excluded.
- •Any kind of coagulation disorder or any first degree family members with major bleeding tendency.
- •Unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).
排除标准
- 未提供
研究组 & 干预措施
Group 2 (high dose-low dose)
Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5
干预措施: Heparin (Drug)
Group 1 (low dose-high dose)
Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5
干预措施: Heparin (Drug)
结局指标
主要结局
Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state
时间窗: day -1 to day 6
ng/ml
Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state
时间窗: day -1 to day 6
µmol/l/min
Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state
时间窗: day -1 to day 6
mmol/L
次要结局
- Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)
- Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)
- Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)
- Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)
- Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)
- Change from baseline in Lipoprotein profiling (very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL) before and after heparin exposure both in fasted and postprandial state(day -1 to day 6)