NCT06933056EARLY_PHASE1RecruitingAccepts Healthy Volunteers
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
University of Michigan
Start Date
9/2/2025
Completion Date
9/1/2026
Summary
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
Eligibility Criteria
Age Range: 18 years to 79 years
Inclusion Criteria:
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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
Interventions
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
Conditions
Platelet Function and Reactivity Tests
Locations
University of Michigan
Ann Arbor, Michigan 48109
United States