Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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