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

University of Michigan

Status and phase: Enrolling; Early Phase 1

Conditions: Platelet Function and Reactivity Tests

Treatments: Drug: Sotagliflozin (SOTA) followed by 3 drugs in a random order; Drug: Eliquis 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06933056

HUM00267102

Details and patient eligibility

About

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

Experimental group

Description:

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.

Treatment:

Drug: Clopidogrel followed by 3 drugs in a random order

Drug: Aspirin followed by 3 drugs in a random order

Drug: Eliquis followed by 3 drugs in a random order

Drug: Sotagliflozin (SOTA) followed by 3 drugs in a random order