RECRUITING

Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pilot study is to gather preliminary data on the (1) contribution of the understudied drug metabolizing enzyme, UDP-glucuronosyltransferase (UGT) 2B17, to the metabolism of a widely used medication, diclofenac, and (2) impact of the UGT2B17 inhibitor and natural product, curcumin, on diclofenac pharmacokinetics. Results will inform future studies aimed to assess the effects of UGT2B17 genetic polymorphisms and co-consumed xenobiotics on the pharmacokinetics and toxicity risk of diclofenac and other UGT2B17 drug substrates.

Official Title

Pilot Study to Assess the Contribution of UGT2B17 and Associated Genetic Polymorphisms on the Pharmacokinetics of Diclofenac Alone and Upon Co-administration With Curcumin

Quick Facts

Study Start:2024-03-01

Study Completion:2026-08-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06053411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Aged from 18-64 years and healthy * Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of diclofenac or curcumin * Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of each study arm * Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the outpatient visit(s) following the 14-hour days * Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms) * Have the time to participate * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study	* Under the age of 18 or over the age of 65 years * Smoke/vape/chew tobacco products * Use cannabis products, including marijuana, hemp, and other THC- or CBD-containing products * Have any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS * History of anemia or any other significant hematologic disorder * History of drug or alcohol addiction or major psychiatric illness * Pregnant or nursing or plan to become pregnant within 3 weeks after participation * History of allergy intolerance to diclofenac or curcumin * Taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of diclofenac or curcumin * Taking any turmeric spice or curcumin supplement * Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or quality of the data * Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk

Inclusion Criteria

Exclusion Criteria

* Aged from 18-64 years and healthy
* Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of diclofenac or curcumin
* Willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of each study arm
* Willing to abstain from consuming any alcoholic beverages for one day prior to any study day, during the 14-hour inpatient days, and for the outpatient visit(s) following the 14-hour days
* Willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms)
* Have the time to participate
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for the subject to comply with the requirements of the study

* Under the age of 18 or over the age of 65 years
* Smoke/vape/chew tobacco products
* Use cannabis products, including marijuana, hemp, and other THC- or CBD-containing products
* Have any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
* History of anemia or any other significant hematologic disorder
* History of drug or alcohol addiction or major psychiatric illness
* Pregnant or nursing or plan to become pregnant within 3 weeks after participation
* History of allergy intolerance to diclofenac or curcumin
* Taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of diclofenac or curcumin
* Taking any turmeric spice or curcumin supplement
* Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or quality of the data
* Out-of-range clinical laboratory value that the study physician considers participation in the study a health risk

Contacts and Locations

Study Contact

Mary F Paine, RPh, PhD

CONTACT

509-358-7759

mary.paine@wsu.edu

Siavosh Naji-Talakar, PharmD, MS

CONTACT

509-358-7739

s.naji-talakar@wsu.edu

Study Locations (Sites)

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, 99202

United States

Collaborators and Investigators

Sponsor: Washington State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2026-08-18

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2026-08-18

Terms related to this study

Keywords Provided by Researchers

Pharmacokinetic

Additional Relevant MeSH Terms

Interaction