Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-25 @ 2:45 PM
Study NCT ID:
NCT05178550
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Lipoprotein Lipase (LPL) levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'ng/ml'}, {'measure': 'Change from baseline in LPL activity before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'µmol/l/min'}, {'measure': 'Change from baseline in Triglycerides (TG) levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'mmol/L'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in apolipoprotein CII (APOCII) levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'mg/L'}, {'measure': 'Change from baseline in APOCIII levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'mg/dl'}, {'measure': 'Change from baseline in total cholesterol levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'mmol/L'}, {'measure': 'Change from baseline in Free fatty acids (FFA) levels before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'mmol/L'}, {'measure': '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', 'timeFrame': 'day -1 to day 6', 'description': 'mmol.L-1'}, {'measure': 'Change from baseline in adverse events (AEs) before and after heparin exposure both in fasted and postprandial state', 'timeFrame': 'day -1 to day 6', 'description': 'Number of events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subject\n* Male or female\n* 18 to 65 years, inclusive, at the time of signing informed consent\n* Body mass index:18.0 kg/m \\^2 to 29.9 kg/m\\^2, inclusive, at the time of signing informed consent\n* Body weight greater than or equal to 50 kg at the time of signing informed consent\n\nExclusion criteria:\n\n* Using tobacco products within 60 days prior to the first drug administration.\n* Any kind of coagulation disorder or any first degree family members with major bleeding tendency.\n* History of anemia, thrombocytopenia, HIT, other blood disorders, or any clinically relevant bleeding (epistaxis).\n* Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 100 days prior to the first dose of heparin.\n* 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.\n* Any kind of coagulation disorder or any first degree family members with major bleeding tendency.\n* Unwillingness to consume the entire high-fat standardized meal (e.g. vegetarians, vegans and subjects who follow special diets).'}, 'identificationModule': {'nctId': 'NCT05178550', 'briefTitle': 'A Study in Healthy Participants Investigating Biomarkers After Exposure to Heparin When Heparin is Administered in the Fasted State or After a High-fat Meal. Heparin, a Registered Drug, is an Anticoagulant (Blood Thinner) That Prevents the Formation of Blood Clots.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NN6633-4955'}, 'secondaryIdInfos': [{'id': '2021-005899-18', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1270-0957', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (low dose-high dose)', 'description': 'Participants receive 25 IU/kg heparin on days 1 and 2, and 50 IU/kg Heparin on days 4 and 5', 'interventionNames': ['Drug: Heparin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (high dose-low dose)', 'description': 'Participants receive 50 IU/kg heparin on days 1 and 2, and 25 IU/kg Heparin on days 4 and 5', 'interventionNames': ['Drug: Heparin']}], 'interventions': [{'name': 'Heparin', 'type': 'DRUG', 'description': 'intravenous \\[iv\\] injection', 'armGroupLabels': ['Group 1 (low dose-high dose)', 'Group 2 (high dose-low dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'http://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}