Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs (NCT06933056) | Clinical Trial Compass
RecruitingEarly Phase 1
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
United States20 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Platelet aggregation
Timeframe: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.