Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT06174961
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2023-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2023-12-08', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)', 'timeFrame': 'Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection'}], 'secondaryOutcomes': [{'measure': 'Difference between interventions in change in incremental plasma heparin', 'timeFrame': 'Peak plasma heparin for 1-8 hours after UFH injection'}, {'measure': 'Difference between interventions in mean incremental aPTT', 'timeFrame': '1-8 hours after UFH injection'}, {'measure': 'Difference between interventions in mean incremental plasma heparin', 'timeFrame': '1-8 hours after UFH injection'}, {'measure': 'Difference between interventions in change in aPTT', 'timeFrame': '4 hours after UFH injection'}, {'measure': 'Difference between interventions in change in plasma heparin', 'timeFrame': '4 hours after UFH injection'}, {'measure': 'Difference between interventions in mean incremental natriuretic peptides', 'timeFrame': '1-8 hours after UFH injection'}, {'measure': 'Difference between interventions in mean incremental follistatin', 'timeFrame': '1-8 hours after UFH injection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Coagulation Disorder']}, 'descriptionModule': {'briefSummary': '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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight 50 kg or more\n* Body Mass Index 18.5-25 kg/m2\n* Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug\n* Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug\n* Signed informed consent form\n\nExclusion Criteria:\n\n* History or sign of bleeding disorders\n* History or sign of kidney disease\n* History or sign of liver disease\n* 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).\n* Daily pharmaceutical treatment\n* Contraindication to increased levels of physical activity (10)\n* Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.\n* 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).\n* Previous treatment with heparins\n* Low levels of anti-thrombin (P-antitrombin(enz.) \\<0,80 kIU/L)'}, 'identificationModule': {'nctId': 'NCT06174961', 'briefTitle': 'The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study', 'orgStudyIdInfo': {'id': '2023-000150-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unfractionated heparin + No exercise', 'description': '15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards.', 'interventionNames': ['Drug: Unfractionated heparin', 'Behavioral: No exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Unfractionated heparin + Double-legged cycle ergometer exercise', 'description': '15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards', 'interventionNames': ['Drug: Unfractionated heparin', 'Behavioral: Double-legged cycle ergometer exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise', 'description': '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', 'interventionNames': ['Drug: Unfractionated heparin', 'Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg']}, {'type': 'EXPERIMENTAL', 'label': 'Unfractionated heparin + Single-legged contralateral cycle ergometer exercise', 'description': '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', 'interventionNames': ['Drug: Unfractionated heparin', 'Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg']}], 'interventions': [{'name': 'Unfractionated heparin', 'type': 'DRUG', 'description': '15,000 units of unfractionated heparin administered in the thigh', 'armGroupLabels': ['Unfractionated heparin + Double-legged cycle ergometer exercise', 'Unfractionated heparin + No exercise', 'Unfractionated heparin + Single-legged contralateral cycle ergometer exercise', 'Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise']}, {'name': 'Double-legged cycle ergometer exercise', 'type': 'BEHAVIORAL', 'description': 'One hour of double-leg cycle ergometer exercise', 'armGroupLabels': ['Unfractionated heparin + Double-legged cycle ergometer exercise']}, {'name': 'Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg', 'type': 'BEHAVIORAL', 'description': 'One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg', 'armGroupLabels': ['Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise']}, {'name': 'Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg', 'type': 'BEHAVIORAL', 'description': 'One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg', 'armGroupLabels': ['Unfractionated heparin + Single-legged contralateral cycle ergometer exercise']}, {'name': 'No exercise', 'type': 'BEHAVIORAL', 'description': 'No exercise', 'armGroupLabels': ['Unfractionated heparin + No exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kristian Karstoft, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kristian Karstoft', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician, Principal Investigator, MD, PhD, DMSc', 'investigatorFullName': 'Kristian Karstoft', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}