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Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

ConditionInteraction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWashington State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diclofenac

    Drug

    25 mg capsule

  • curcumin

    Dietary supplement

    2,000 mg tablet

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Arm 1: diclofenac alone (baseline)Experimental treatment 1 intervention
Group B: Arm 2: diclofenac + curcuminExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Diclofenac area under the concentration vs. time curve (AUC) in UGT2B17 extensive metabolizers (EMs)

Diclofenac AUC in UGT2B17 EMs

Time frame
0-12 hours
2

Diclofenac AUC in poor metabolizers (PMs)

Diclofenac AUC in UGT2B17 PMs

Time frame
0-12 hours
3

Diclofenac AUC in EMs in the presence of curcumin

Diclofenac AUC in UGT2B17 EMs in the presence of curcumin

Time frame
0-12 hours
4

Diclofenac maximum concentration (Cmax) in EMs

Diclofenac Cmax in UGT2B17 EMs

Time frame
0-12 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington State University

Lead sponsor

Source ClinicalTrials.gov
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