Clinical trial NCT06933056: Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
Official title: Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Platelet Function and Reactivity Tests
Keywords: Sotagliflozin
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Lexicon Pharmaceuticals
First posted: 2025-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.
Primary purpose: PREVENTION

Brief 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: 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

Primary outcomes:
measure: Platelet aggregation
timeFrame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.
Secondary outcomes:
measure: Platelet granule secretion
timeFrame: Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.
measure: Total thrombus activation with T-TAS
timeFrame: Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.
measure: Thromboelastography (TEG)
timeFrame: Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.
measure: Platelet integrin activation
timeFrame: Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michael Holinstat, PhD
role: PRINCIPAL_INVESTIGATOR
References: