Understanding how a specific enzyme affects the metabolism of diclofenac
Pilot Study to Assess the Contribution of UGT2B17 and Associated Genetic Polymorphisms on the Pharmacokinetics of Diclofenac Alone and Upon Co-administration With Curcumin
This study is testing how a specific enzyme affects how the body processes diclofenac, a common anti-inflammatory drug, and whether curcumin can change that process in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Washington State University Academic / other |
| Locations | 1 site (Spokane, Washington) |
| Trial ID | NCT06053411 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the role of the enzyme UDP-glucuronosyltransferase (UGT) 2B17 in the metabolism of diclofenac, a commonly used anti-inflammatory medication. The study will also examine how curcumin, a natural product and UGT2B17 inhibitor, influences the pharmacokinetics of diclofenac. By analyzing the genetic variations of UGT2B17 and their impact on drug metabolism, the research seeks to provide insights that could inform future studies on the safety and efficacy of diclofenac and other drugs metabolized by UGT2B17. Participants will be healthy adults aged 18-64 who meet specific eligibility criteria and will undergo controlled interventions involving diclofenac and curcumin.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-64 who are not taking any medications or supplements that could affect drug metabolism.
Not a fit: Patients with existing health conditions or those taking medications that alter pharmacokinetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of diclofenac metabolism, potentially reducing the risk of adverse effects for patients.
How similar studies have performed: While the specific focus on UGT2B17 and diclofenac is relatively novel, previous studies have explored the pharmacokinetics of other drugs metabolized by UGT enzymes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Spokane, Washington
- Washington State University College of Pharmacy and Pharmaceutical Sciences — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Mary F Paine, RPh, PhD
- Email: mary.paine@wsu.edu
- Phone: 509-358-7759
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.