drugset / Trial / NCT04449471
Naproxen Pharmacogenetic Study (Project 1, Aim 2)
Phase 4
Unknown
30 enrolled
University of Washington
National Institute of General Medical Sciences (NIGMS) · collabOregon Health and Science University · collab
NaSingle-groupOpen-labelBasic science
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 naproxen. CYP2C9 activity will be evaluated by measurement of O-desmethyl naproxen and unchanged naproxen in 24-hour urine following administration of a single oral dose of naproxen (Aleve) in Yup'ik Alaska Native adult men and women who were previously determined in a separate observational study to be homozygous for the CYP2C9\*1 allele or a carrier of the CYP2C9 M1L allele.
Timeline
- Start
- 2016-01-12
- Primary completion
- 2021-07-31
- Completion
- 2022-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | 220 mg | Oral |
Indications
No indication recorded.