Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT06933056
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C575681', 'term': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'id': 'C522181', 'term': 'apixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet aggregation', 'timeFrame': 'Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.', 'description': 'Measured from blood samples'}], 'secondaryOutcomes': [{'measure': 'Platelet granule secretion', 'timeFrame': 'Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.', 'description': 'Measured from blood samples'}, {'measure': 'Total thrombus activation with T-TAS', 'timeFrame': 'Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.', 'description': 'Measured from blood samples'}, {'measure': 'Thromboelastography (TEG)', 'timeFrame': 'Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.', 'description': 'Measured from blood samples'}, {'measure': 'Platelet integrin activation', 'timeFrame': 'Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.', 'description': 'Measured from blood samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sotagliflozin'], 'conditions': ['Platelet Function and Reactivity Tests']}, 'descriptionModule': {'briefSummary': 'This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n* Students under the direct supervision of Dr. Michael Holinstat\n* Subjects diagnosed with Type I diabetes or those with ketoacidosis\n* Subjects with a history of alcohol abuse, pancreatitis or pancreatic surgery, or subjects taking a ketogenic diet\n* Women who self-identify as being pregnant or who are planning to become pregnant during the 14 week study will be excluded from the study, as are those who are breastfeeding (women enrolled in the study will be given a urine pregnancy test at the start of each drug administration period to confirm pregnancy status)\n* Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozin are excluded\n* have active bleeding, or who have who have a history of balanitis or balanoposthitis, genital mycotic infections, or a planned elective surgical/dental procedure 1 month prior to or following completion of study\n* Subjects who have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDS; examples of NSAIDS are Ibuprofen (Advil, Motrin) and Naproxen (Aleve)) or aspirin within 7 days prior to the study or anticoagulants within 10 days prior to the study\n* individuals currently taking SSRI's (for example, Fluoxetine (Prozac), Sertraline (Zoloft), Paroxetine (Paxil), Citalopram (Celexa), and Escitalopram (Lexapro).), SNRI's (Duloxetine (Cymbalta), Venlafaxine (Effexor XR), Desvenlafaxine (Pristiq), and Levomilnacipran (Fetzima)), lithium, or omeprazole/esomeprazole\n* Subjects less than or equal to 60 kg will be excluded\n* Subjects with a creatinine greater than or equal to 1.5 mg/dl will be excluded"}, 'identificationModule': {'nctId': 'NCT06933056', 'briefTitle': 'Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study', 'orgStudyIdInfo': {'id': 'HUM00267102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents', 'description': 'Platelet responsiveness will be assessed in the blood from subjects administered sotagliflozin, aspirin, clopidogrel, or apixaban in randomized order given as a single drug administration.', 'interventionNames': ['Drug: Sotagliflozin (SOTA) followed by 3 drugs in a random order', 'Drug: Aspirin followed by 3 drugs in a random order', 'Drug: Clopidogrel followed by 3 drugs in a random order', 'Drug: Eliquis followed by 3 drugs in a random order']}], 'interventions': [{'name': 'Sotagliflozin (SOTA) followed by 3 drugs in a random order', 'type': 'DRUG', 'description': '400 mg/day SOTA Each drug will be given daily for 2 weeks.', 'armGroupLabels': ['Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents']}, {'name': 'Aspirin followed by 3 drugs in a random order', 'type': 'DRUG', 'description': '81 mg/day Aspirin Each drug will be given daily for 2 weeks.', 'armGroupLabels': ['Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents']}, {'name': 'Clopidogrel followed by 3 drugs in a random order', 'type': 'DRUG', 'description': '75 mg/day clopidogrel Each drug will be given daily for 2 weeks.', 'armGroupLabels': ['Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents']}, {'name': 'Eliquis followed by 3 drugs in a random order', 'type': 'DRUG', 'otherNames': ['Apixaban'], 'description': '5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.', 'armGroupLabels': ['Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Prieur', 'role': 'CONTACT', 'email': 'famanda@med.umich.edu', 'phone': '734-763-8824'}, {'name': 'Michael Holinstat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed Abdel-latif, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Amanda Prieur', 'role': 'CONTACT', 'email': 'famanda@med.umich.edu', 'phone': '734-763-8824'}], 'overallOfficials': [{'name': 'Michael Holinstat, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lexicon Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmacology, Professor of Internal Medicine and Professor of Surgery', 'investigatorFullName': 'Michael Holinstat', 'investigatorAffiliation': 'University of Michigan'}}}}