Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
NCT ID: NCT06933056
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2025-09-02
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents
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.
Sotagliflozin (SOTA) followed by 3 drugs in a random order
400 mg/day SOTA Each drug will be given daily for 2 weeks.
Aspirin followed by 3 drugs in a random order
81 mg/day Aspirin Each drug will be given daily for 2 weeks.
Clopidogrel followed by 3 drugs in a random order
75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
Eliquis followed by 3 drugs in a random order
5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.
Interventions
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Sotagliflozin (SOTA) followed by 3 drugs in a random order
400 mg/day SOTA Each drug will be given daily for 2 weeks.
Aspirin followed by 3 drugs in a random order
81 mg/day Aspirin Each drug will be given daily for 2 weeks.
Clopidogrel followed by 3 drugs in a random order
75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
Eliquis followed by 3 drugs in a random order
5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
79 Years
ALL
Yes
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Michael Holinstat
Professor of Pharmacology, Professor of Internal Medicine and Professor of Surgery
Principal Investigators
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Michael Holinstat, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00267102
Identifier Type: -
Identifier Source: org_study_id
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