The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)
研究概览
简要总结
The aim of this project is to assess the influence of exercise on pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of subcutaneously (sc) administered unfractionated heparin (UFH). It is hypothesized that exercise will increase the systemic exposure (PK) and therefore the clinical effects (PD) of the sc administered UFH.
To assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have UFH injected sc in the thigh, followed by different exercise interventions (one per experimental day). Blood sampling, with the aim of assessing PK and PD will be performed during the following hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight 50 kg or more
- •Body Mass Index 18.5-25 kg/m2
- •Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug
- •Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug
- •Signed informed consent form
排除标准
- •History or sign of bleeding disorders
- •History or sign of kidney disease
- •History or sign of liver disease
- •Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
- •Daily pharmaceutical treatment
- •Contraindication to increased levels of physical activity (10)
- •Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.
- •Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
- •Previous treatment with heparins
- •Low levels of anti-thrombin (P-antitrombin(enz.) <0,80 kIU/L)
研究组 & 干预措施
Unfractionated heparin + No exercise
15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards.
干预措施: Unfractionated heparin (Drug)
Unfractionated heparin + No exercise
15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards.
干预措施: No exercise (Behavioral)
Unfractionated heparin + Double-legged cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards
干预措施: Unfractionated heparin (Drug)
Unfractionated heparin + Double-legged cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards
干预措施: Double-legged cycle ergometer exercise (Behavioral)
Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in leg where unfractionated heparin injection is given will be performed for 1 hour afterwards
干预措施: Unfractionated heparin (Drug)
Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in leg where unfractionated heparin injection is given will be performed for 1 hour afterwards
干预措施: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg (Behavioral)
Unfractionated heparin + Single-legged contralateral cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in contralateral leg to where unfractionated heparin injection is given will be performed for 1 hour afterwards
干预措施: Unfractionated heparin (Drug)
Unfractionated heparin + Single-legged contralateral cycle ergometer exercise
15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in contralateral leg to where unfractionated heparin injection is given will be performed for 1 hour afterwards
干预措施: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg (Behavioral)
结局指标
主要结局
Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)
时间窗: Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection
次要结局
- Difference between interventions in mean incremental aPTT(1-8 hours after UFH injection)
- Difference between interventions in mean incremental plasma heparin(1-8 hours after UFH injection)
- Difference between interventions in change in aPTT(4 hours after UFH injection)
- Difference between interventions in change in plasma heparin(4 hours after UFH injection)
- Difference between interventions in mean incremental follistatin(1-8 hours after UFH injection)
- Difference between interventions in change in incremental plasma heparin(Peak plasma heparin for 1-8 hours after UFH injection)
- Difference between interventions in mean incremental natriuretic peptides(1-8 hours after UFH injection)
研究者
Kristian Karstoft
Chief Physician, Principal Investigator, MD, PhD, DMSc
University Hospital Bispebjerg and Frederiksberg