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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unfractionated heparin + No exercise | Experimental | 15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards. |
|
| Unfractionated heparin + Double-legged cycle ergometer exercise | Experimental | 15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards |
|
| Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise | Experimental | 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 |
|
| Unfractionated heparin + Single-legged contralateral cycle ergometer exercise | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfractionated heparin | Drug | 15,000 units of unfractionated heparin administered in the thigh |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 aPTT | 1-8 hours after UFH injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristian Karstoft, MD, DMSc | Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology | Copenhagen | 2400 | Denmark |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 28, 2026 | |
| Reset | May 20, 2026 |
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| Double-legged cycle ergometer exercise | Behavioral | One hour of double-leg cycle ergometer exercise |
|
| Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg | Behavioral | One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg |
|
| Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg | Behavioral | One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg |
|
| No exercise | Behavioral | No exercise |
|
| 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 natriuretic peptides | 1-8 hours after UFH injection |
| Difference between interventions in mean incremental follistatin | 1-8 hours after UFH injection |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 20, 2026 |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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