Naproxen Pharmacogenetic Study (Project 1, Aim 2)

NCT04449471 | Unknown Phase 4 FDA Drug

• 2 other identifiers: SITE000006715P01GM116691
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Keywords

CYP2C9; naproxen; polymorphism

Outcome Measures

Primary Outcomes (1)

• 6-O-desmethyl naproxen/naproxen ratio

  A ratio of the total mount of 6-O-desmethyl naproxen/unchanged naproxen in 24-hour urine

  24-hours

Study Arms (1)

Naproxen Tablet

EXPERIMENTAL

Subjects will received a single 220-mg dose of naproxen sodium (Aleve) by mouth.

Drug: Naproxen tablet

Interventions

Naproxen tablet DRUG

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.

Also known as: Aleve

Naproxen Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Oregon Health and Science University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

RECRUITING

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Kenneth E. Thummel, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth E. Thummel, PhD

CONTACT

205-543-0819; thummel@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: Pharmaceutics

Model Details: Healthy adults with predetermined CYP2C9 genotype will receive the probe drug, naproxen.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: January 12, 2016
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2022
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

US (1)