Platelet Function and Reactivity Tests
Conditions
Keywords
Sotagliflozin
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.
Interventions
DRUGSotagliflozin (SOTA) followed by 3 drugs in a random order
400 mg/day SOTA Each drug will be given daily for 2 weeks.
DRUGAspirin followed by 3 drugs in a random order
81 mg/day Aspirin Each drug will be given daily for 2 weeks.
DRUGClopidogrel followed by 3 drugs in a random order
75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
DRUGEliquis followed by 3 drugs in a random order
5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.
Sponsors
Lexicon Pharmaceuticals
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet aggregation | Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days. | Measured from blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactAmanda Prieur
Outcome results
None listed