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Naproxen Pharmacogenetic Study (Project 1, Aim 2)

NCT04449471 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-29

No results posted yet for this study

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.

Conditions

  • Pharmacogenetics

Interventions

DRUG

Naproxen tablet

For this single intervention arm, each subject will receive a single 220-mg dose of naproxen sodium (Aleve), followed by urine collection for 24-hours.

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Kenneth E. Thummel, PhD · University of Washington

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-12
Primary Completion
2021-07-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449471 on ClinicalTrials.gov