Blood Coagulation Disorder
Conditions
Brief summary
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.
Interventions
DRUGUnfractionated heparin
15,000 units of unfractionated heparin administered in the thigh
BEHAVIORALDouble-legged cycle ergometer exercise
One hour of double-leg cycle ergometer exercise
BEHAVIORALSingle-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg
One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg
BEHAVIORALSingle-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg
One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg
BEHAVIORALNo exercise
No exercise
Sponsors
Kristian Karstoft
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between interventions in change in incremental activated partial thromboplastin time (aPTT) | Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| Difference between interventions in mean incremental follistatin | 1-8 hours after UFH injection |
| Difference between interventions in change in plasma heparin | 4 hours after UFH injection |
Countries
Denmark
Outcome results
None listed