Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT06053411
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Interaction

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Diclofenac — DRUG
    25 mg capsule
  • curcumin — DIETARY_SUPPLEMENT
    2,000 mg tablet

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jun 2026
Primary completion
Aug 18, 2026
Completion
Dec 18, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1: diclofenac alone (baseline)
    A single dose of diclofenac (25 mg capsule) will be administered by mouth to 5 participants (minimum 2 females) genotyped as extensive metabolizers (Arm 1A) and 5 participants (minimum 2 females) genotyped as poor metabolizers (Arm 1B). Plasma and urine will be collected from 0-12 hours. A washout of at least 3 days will elapse between Arm 1 and Arm 2.
  • Experimental: Arm 2: diclofenac + curcumin
    A single oral dose of diclofenac (25 mg capsule) and a single oral dose of curcumin (2,000 mg tablet) will be administered by mouth to the 5 participants genotyped as extensive metabolizers. Plasma and urine will be collected from 0-12 hours.

Primary Outcome Measure

Diclofenac area under the concentration vs. time curve (AUC) in UGT2B17 extensive metabolizers (EMs) [ Time Frame: 0-12 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State University College of Pharmacy and Pharmaceutical SciencesSpokaneWashington99202
Mary F Paine, RPh, PhD
[email protected]
509-358-7759
Deena Hadi, BS
[email protected]
509-368-6692
Mary F Paine, RPh, PhD (PRINCIPAL_INVESTIGATOR)
Matthew Layton, MD, PhD (SUB_INVESTIGATOR)
John White, ParmD, PA-C (SUB_INVESTIGATOR)

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By research site
Washington State University College of Pharmacy and Pharmaceutical Sciences· Spokane, WA

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