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

Conditions

• Platelet Function and Reactivity Tests

Eligibility Criteria

Sex

ALL

Age

18 Years - 79 Years

Healthy Volunteers

Accepted

Interventions

• Sotagliflozin (SOTA) followed by 3 drugs in a random order — DRUG
  400 mg/day SOTA Each drug will be given daily for 2 weeks.
• Aspirin followed by 3 drugs in a random order — DRUG
  81 mg/day Aspirin Each drug will be given daily for 2 weeks.
• Clopidogrel followed by 3 drugs in a random order — DRUG
  75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
• Eliquis followed by 3 drugs in a random order — DRUG
  5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.

Study Details

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

Key Dates

Start date

Sep 2, 2025

Status verified

Sep 2025

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: 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.

Primary Outcome Measure

Platelet aggregation [ Time Frame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days. ]

Central Contacts

• Amanda Prieur
  734-763-8824
  [email protected]

Locations (1)

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