Status:
COMPLETED
Asprin Dosing Estimator in Healthy Adults
Lead Sponsor:
University of Utah
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Aspirin Sensitivity
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is...
Detailed Description
AIM 1: Determine urine TXB2, platelet aggregation function testing (VerifyNow® ASA Test), salicylate level, CBC with differential, and hs-CRP, in 18 healthy volunteers across BMI classes of 22-25 (Nor...
Eligibility Criteria
Inclusion
- Ages 18-55 years old (male or female)
- Healthy Volunteers (medication free without acute or chronic significant health problems or pathologies)
Exclusion
- History of asthma
- History of chronic bronchitis
- History of emphysema
- History of renal impairment (eGFR \< 30 ml/min)
- History of hypertension (reviewed by study staff)
- History of hyperlipidemia
- History of diabetes
- History of smoking (within last month)
- Current depression or anxiety requiring medication therapy
- Inability to finish the study for any reason
- Any current pathological condition outside of normal range
- Thrombocytopenia (platelet count \< 150 K/µL)
- Other known platelet disorders (eg. von Willebrand disease, Glanzmann thrombasthenia, Bernard-Soulier Syndrome)
- Current use of dipyradamole, PGY 12 inhibitors, NSAIDs
- Or as otherwise determined by the investigative team
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04040465
Start Date
February 15 2021
End Date
October 30 2021
Last Update
March 11 2022
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112