Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs

Early Phase 1

Not yet recruiting

• Conditions: Platelet Function and Reactivity Tests
• 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

• Registration Number: NCT06933056
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents	Sotagliflozin (SOTA) followed by 3 drugs in a random order	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.
Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents	Aspirin followed by 3 drugs in a random order	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.
Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents	Clopidogrel followed by 3 drugs in a random order	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.
Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents	Eliquis followed by 3 drugs in a random order	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.

Primary Outcome Measures

Name	Time	Method
Platelet aggregation	Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.	Measured from blood samples

Secondary Outcome Measures

Name	Time	Method
Platelet granule secretion	Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.	Measured from blood samples
Total thrombus activation with T-TAS	Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.	Measured from blood samples
Thromboelastography (TEG)	Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.	Measured from blood samples
Platelet integrin activation	Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.	Measured from blood samples

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States