Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06053411

Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Led by Washington State University · Updated on 2024-11-18

30

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged from 18 to 64 years and healthy
  • Not taking any medications or dietary/herbal supplements that affect diclofenac or curcumin metabolism
  • Willing to avoid caffeine the evening before and morning of study days
  • Willing to avoid alcohol one day before and during study inpatient days and outpatient visits
  • Willing to use a secondary birth control method excluding hormonal-based methods
  • Able and willing to provide written informed consent and comply with study requirements
  • Have enough time to participate in the study
Not Eligible

You will not qualify if you...

  • Under 18 or over 65 years old
  • Use tobacco products such as smoking, vaping, or chewing
  • Use cannabis products including marijuana, hemp, THC, or CBD
  • Have major or chronic illnesses like kidney, liver, diabetes, heart disease, lung disease, cancer, or HIV/AIDS
  • History of anemia or significant blood disorders
  • History of drug or alcohol addiction or major psychiatric illness
  • Pregnant, nursing, or planning pregnancy within 3 weeks after the study
  • Allergy or intolerance to diclofenac or curcumin
  • Taking medications or supplements that alter diclofenac or curcumin metabolism
  • Currently taking turmeric spice or curcumin supplements
  • Any condition or abnormality that may affect safety or data quality as judged by the investigator
  • Clinical lab values outside normal range posing health risk as determined by study physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington State University College of Pharmacy and Pharmaceutical Sciences

Spokane, Washington, United States, 99202

Actively Recruiting

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Research Team

M

Mary F Paine, RPh, PhD

CONTACT

S

Siavosh Naji-Talakar, PharmD, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac | DecenTrialz