Status:
UNKNOWN
Naproxen Pharmacogenetic Study (Project 1, Aim 2)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Oregon Health and Science University
National Institute of General Medical Sciences (NIGMS)
Conditions:
Pharmacogenetics
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a mechanism-based study in healthy adults to determine the effect of the CYP2C9 M1L gene polymorphism on the functional activity of the encoded CYP2C9 enzyme towards the probe substrate naprox...
Detailed Description
This pharmacogenetics study will test the hypothesis that inheritance of a M1L variant in the CYP2C9 gene, which was first discovered in Yup'ik Alaska Native people, causes complete loss of function i...
Eligibility Criteria
Inclusion
- No history of significant medical conditions including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, or history of asthma, urticaria, or allergic-type reactions with aspirin (ASA) or other NSAID (nonsteroidal anti-inflammatory drug).
- Both males or females 18 years and older.
- Self-identified as Yup'ik or Cup'ik
- Able to read and understand English or Yup'ik.
- Able to provide informed consent.
- Women not currently pregnant or lactating.
Exclusion
- Individuals with any significant chronic medical condition, including cardiac, pulmonary, hepatic, gastrointestinal, or renal disease, HIV, or history of asthma, urticaria, or allergic-type reactions with aspirin (ASA) or other NSAID
- Individuals less than 18 years of age.
- Individuals unable to read and understand English or Yup'ik.
- Individuals unable to provide informed consent.
- Individuals taking drugs or natural products known to affect the metabolic activity of CYP2C9 (e.g., rifampin, carbamazepine, barbiturates, phenytoin, valproic acid, fluconazole, ketoconazole, miconazole, amiodarone, fluvastatin and milk thistle.
- Women who are pregnant or lactating.
Key Trial Info
Start Date :
January 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04449471
Start Date
January 12 2016
End Date
July 31 2022
Last Update
June 29 2020
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098