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Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
RecruitingEarly phase 1Healthy volunteers welcome
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study
Who can join
Ages 18 to 79 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: \- Exclusion Criteria: * Students under the direct supervision of Dr. Michael Holinstat * Subjects diagnosed with Type I diabetes or those with ketoacidosis * Subjects with a history of alcohol abuse, pancreatitis or pancreatic surgery, or subjects taking a ketogenic diet * 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) * Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozin are excluded * 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 * 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 * 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 * Subjects less than or equal to 60 kg will be excluded * Subjects with a creatinine greater than or equal to 1.5 mg/dl will be excluded
About the study
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
What is being tested
- 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 (drug)
Sponsor: University of Michigan · Participants: 20 · Started: Sep 2, 2025
Contact the study team
- Amanda Prieur · Phone: 734-763-8824
Official record on ClinicalTrials.gov — NCT06933056
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.