InteractionEarly Phase 1NCT06053411
Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac
A Early Phase 1 study testing Diclofenac and curcumin in people with Interaction, run by Washington State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Interaction
- What is being tested?
- Diclofenac and curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 18 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington State University College of Pharmacy and Pharmaceutical Sciences
Spokane, Washington, 99202
Mary F Paine, RPh, PhD, 509-358-7759, mary.paine@wsu.edu
Deena Hadi, BS, 509-368-6692, deena.hadi@wsu.edu
About this study
Official title: Pilot Study to Assess the Contribution of UGT2B17 and Associated Genetic Polymorphisms on the Pharmacokinetics of Diclofenac Alone and Upon Co-administration With Curcumin
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.
Read the detailed description
Diclofenac, a widely used non-steroidal anti-inflammatory drug, has been linked to severe adverse effects such as gastrointestinal ulcers and bleeding and cardiotoxicity. Based on cardiotoxicity reports, US and European regulatory agencies withdrew over-the-counter (OTC) diclofenac, requiring the drug to be a prescription-only medication. However, diclofenac remains OTC in many countries, including Australia, China, and India, among others. Reported metabolic pathways of diclofenac in the liver are mediated by the prominent drug metabolizing enzyme, cytochrome P450 (CYP) 2C9, and the conjugative enzyme, UDP-glucuronosyltransferase (UGT) 2B7. However, recent in vitro and in silico data indicated that diclofenac is metabolized almost exclusively by a less-studied UGT, UGT2B17, in the intestine.
UGT2B17 is among the most genetically polymorphic enzymes, with highly prevalent copy number variations (CNVs). Individuals homozygous for the null allele, UGT2B17*2 (CNV=0), are considered poor metabolizers (PMs), whereas those homozygous for the reference allele, UGT2B17*1/*1 (CNV=2), are considered extensive metabolizers (EMs). Deletion of this gene may lead to large interindividual variability in the pharmacokinetics - and toxicity risk - for patients taking diclofenac and other UGT2B17 substrates, including vorinostat, MK7426, tamoxifen, exemestane, and testosterone. Collectively, considering UGT2B17 CNVs on the metabolism of these drugs is critical to ensure consistent and optimum safety, efficacy, and patient outcomes.
Recent preliminary data showed that curcumin, a principal curcuminoid of the natural product turmeric, is a potent inhibitor of UGT2B17. Turmeric is used worldwide and was the 2nd top-selling herbal supplement in the US in 2021, with nearly $100 million in total sales. Considering both turmeric/curcumin and diclofenac are used for arthritis and other inflammatory conditions, there is a high likelihood of patients co-consuming curcumin and diclofenac, raising concerns for variable diclofenac pharmacokinetics and toxicity risk.
The purpose of this pilot study is to gather preliminary data on the (1) contribution of UGT2B17 to diclofenac metabolism and (2) impact of curcumin co-administration on diclofenac pharmacokinetics. Results will inform future studies aimed to evaluate the effects of UGT2B17 genetic polymorphisms and co-consumed xenobiotics on the pharmacokinetics and toxicity risk of diclofenac and other UGT2B17 drug substrates.
- Conditions
- Interaction
- Being tested
- Diclofenac, curcumin
- Keywords
- Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Also called Voltaren
25 mg capsule
curcuminDietary supplement
2,000 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: diclofenac alone (baseline) | Experimental | 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. Receives: Drug: Diclofenac |
| Arm 2: diclofenac + curcumin | Experimental | 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. Receives: Drug: Diclofenac; Dietary Supplement: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diclofenac area under the concentration vs. time curve (AUC) in UGT2B17 extensive metabolizers (EMs)
Diclofenac AUC in UGT2B17 EMs
Measured: 0-12 hours
Diclofenac AUC in poor metabolizers (PMs)
Diclofenac AUC in UGT2B17 PMs
Measured: 0-12 hours
Diclofenac AUC in EMs in the presence of curcumin
Diclofenac AUC in UGT2B17 EMs in the presence of curcumin
Measured: 0-12 hours
Diclofenac maximum concentration (Cmax) in EMs
Diclofenac Cmax in UGT2B17 EMs
Measured: 0-12 hours
Diclofenac Cmax in PMs
Diclofenac Cmax in UGT2B17 PMs
Measured: 0-12 hours
Diclofenac Cmax in EMs in the presence of curcumin
Diclofenac Cmax in UGT2B17 EMs in the presence of curcumin
Measured: 0-12 hours
Diclofenac renal clearance (CLr) in EMs
Diclofenac CLr in UGT2B17 EMs
Measured: 0-12 hours
Diclofenac CLr in PMs
Diclofenac CLr in UGT2B17 PMs
Measured: 0-12 hours
Diclofenac CLr in EMs in the presence of curcumin
Diclofenac CLr in UGT2B17 EMs in the presence of curcumin
Measured: 0-12 hours
Diclofenac half-life (t1/2) in EMs
Diclofenac t1/2 in UGT2B17 EMs
Measured: 0-12 hours
Diclofenac half-life (t1/2) in PMs
Diclofenac t1/2 in UGT2B17 PMs
Measured: 0-12 hours
Diclofenac half-life (t1/2) in EMs in the presence of curcumin
Diclofenac t1/2 in UGT2B17 EMs in the presence of curcumin
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Mar 2024
- Primary completion18 Aug 2027 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Paine, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053411
- Sponsor's protocol ID
- 20104
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schjerning AM, McGettigan P, Gislason G. Cardiovascular effects and safety of (non-aspirin) NSAIDs. Nat Rev Cardiol. 2020 Sep;17(9):574-584. doi: 10.1038/s41569-020-0366-z. Epub 2020 Apr 22.
PubMed 32322101Whirl-Carrillo M, Huddart R, Gong L, Sangkuhl K, Thorn CF, Whaley R, Klein TE. An Evidence-Based Framework for Evaluating Pharmacogenomics Knowledge for Personalized Medicine. Clin Pharmacol Ther. 2021 Sep;110(3):563-572. doi: 10.1002/cpt.2350. Epub 2021 Jul 22.
PubMed 34216021Ahire D, Heyward S, Prasad B. Intestinal Metabolism of Diclofenac by Polymorphic UGT2B17 Correlates with its Highly Variable Pharmacokinetics and Safety across Populations. Clin Pharmacol Ther. 2023 Jul;114(1):161-172. doi: 10.1002/cpt.2907. Epub 2023 Apr 29.
PubMed 37042794Xue Y, Sun D, Daly A, Yang F, Zhou X, Zhao M, Huang N, Zerjal T, Lee C, Carter NP, Hurles ME, Tyler-Smith C. Adaptive evolution of UGT2B17 copy-number variation. Am J Hum Genet. 2008 Sep;83(3):337-46. doi: 10.1016/j.ajhg.2008.08.004. Epub 2008 Aug 28.
PubMed 18760392Wang YH, Trucksis M, McElwee JJ, Wong PH, Maciolek C, Thompson CD, Prueksaritanont T, Garrett GC, Declercq R, Vets E, Willson KJ, Smith RC, Klappenbach JA, Opiteck GJ, Tsou JA, Gibson C, Laethem T, Panorchan P, Iwamoto M, Shaw PM, Wagner JA, Harrelson JC. UGT2B17 genetic polymorphisms dramatically affect the pharmacokinetics of MK-7246 in healthy subjects in a first-in-human study. Clin Pharmacol Ther. 2012 Jul;92(1):96-102. doi: 10.1038/clpt.2012.20. Epub 2012 Jun 6.
PubMed 22669291
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Contribution of UGT2B17 and Associated Genetic Polymorphisms on the Pharmacokinetics of Diclofenac Alone and Upon Co-administration With Curcumin
- ClinicalTrials.gov ID
- NCT06053411
- Acronym / sponsor ID
- 20104
- Conditions
- Interaction
- Keywords
- Pharmacokinetic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 18 Aug 2027 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Diclofenac, a widely used non-steroidal anti-inflammatory drug, has been linked to severe adverse effects such as gastrointestinal ulcers and bleeding and cardiotoxicity. Based on cardiotoxicity reports, US and European regulatory agencies withdrew over-the-counter (OTC) diclofenac, requiring the drug to be a prescription-only medication. However, diclofenac remains OTC in many countries, including Australia, China, and India, among others. Reported metabolic pathways of diclofenac in the liver are mediated by the prominent drug metabolizing enzyme, cytochrome P450 (CYP) 2C9, and the conjugative enzyme, UDP-glucuronosyltransferase (UGT) 2B7. However, recent in vitro and in silico data indicated that diclofenac is metabolized almost exclusively by a less-studied UGT, UGT2B17, in the intestine.
UGT2B17 is among the most genetically polymorphic enzymes, with highly prevalent copy number variations (CNVs). Individuals homozygous for the null allele, UGT2B17*2 (CNV=0), are considered poor metabolizers (PMs), whereas those homozygous for the reference allele, UGT2B17*1/*1 (CNV=2), are considered extensive metabolizers (EMs). Deletion of this gene may lead to large interindividual variability in the pharmacokinetics - and toxicity risk - for patients taking diclofenac and other UGT2B17 substrates, including vorinostat, MK7426, tamoxifen, exemestane, and testosterone. Collectively, considering UGT2B17 CNVs on the metabolism of these drugs is critical to ensure consistent and optimum safety, efficacy, and patient outcomes.
Recent preliminary data showed that curcumin, a principal curcuminoid of the natural product turmeric, is a potent inhibitor of UGT2B17. Turmeric is used worldwide and was the 2nd top-selling herbal supplement in the US in 2021, with nearly $100 million in total sales. Considering both turmeric/curcumin and diclofenac are used for arthritis and other inflammatory conditions, there is a high likelihood of patients co-consuming curcumin and diclofenac, raising concerns for variable diclofenac pharmacokinetics and toxicity risk.
The purpose of this pilot study is to gather preliminary data on the (1) contribution of UGT2B17 to diclofenac metabolism and (2) impact of curcumin co-administration on diclofenac pharmacokinetics. Results will inform future studies aimed to evaluate the effects of UGT2B17 genetic polymorphisms and co-consumed xenobiotics on the pharmacokinetics and toxicity risk of diclofenac and other UGT2B17 drug substrates.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: diclofenac alone (baseline) | Experimental | Drug: DiclofenacA 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. |
| Arm 2: diclofenac + curcumin | Experimental | Drug: Diclofenac, Dietary Supplement: curcuminA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiclofenacAlso: Voltaren25 mg capsule | Drug | Arm 1: diclofenac alone (baseline), Arm 2: diclofenac + curcumin |
| curcumin2,000 mg tablet | Dietary supplement | Arm 2: diclofenac + curcumin |
Primary outcome
Diclofenac area under the concentration vs. time curve (AUC) in UGT2B17 extensive metabolizers (EMs)
Time frame: 0-12 hours
Diclofenac AUC in UGT2B17 EMs
Diclofenac AUC in poor metabolizers (PMs)
Time frame: 0-12 hours
Diclofenac AUC in UGT2B17 PMs
Diclofenac AUC in EMs in the presence of curcumin
Time frame: 0-12 hours
Diclofenac AUC in UGT2B17 EMs in the presence of curcumin
Diclofenac maximum concentration (Cmax) in EMs
Time frame: 0-12 hours
Diclofenac Cmax in UGT2B17 EMs
Diclofenac Cmax in PMs
Time frame: 0-12 hours
Diclofenac Cmax in UGT2B17 PMs
Diclofenac Cmax in EMs in the presence of curcumin
Time frame: 0-12 hours
Diclofenac Cmax in UGT2B17 EMs in the presence of curcumin
Diclofenac renal clearance (CLr) in EMs
Time frame: 0-12 hours
Diclofenac CLr in UGT2B17 EMs
Diclofenac CLr in PMs
Time frame: 0-12 hours
Diclofenac CLr in UGT2B17 PMs
Diclofenac CLr in EMs in the presence of curcumin
Time frame: 0-12 hours
Diclofenac CLr in UGT2B17 EMs in the presence of curcumin
Diclofenac half-life (t1/2) in EMs
Time frame: 0-12 hours
Diclofenac t1/2 in UGT2B17 EMs
Diclofenac half-life (t1/2) in PMs
Time frame: 0-12 hours
Diclofenac t1/2 in UGT2B17 PMs
Diclofenac half-life (t1/2) in EMs in the presence of curcumin
Time frame: 0-12 hours
Diclofenac t1/2 in UGT2B17 EMs in the presence of curcumin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 32322101Schjerning AM, McGettigan P, Gislason G. Cardiovascular effects and safety of (non-aspirin) NSAIDs. Nat Rev Cardiol. 2020 Sep;17(9):574-584. doi: 10.1038/s41569-020-0366-z. Epub 2020 Apr 22.
- Background: PubMed 34216021Whirl-Carrillo M, Huddart R, Gong L, Sangkuhl K, Thorn CF, Whaley R, Klein TE. An Evidence-Based Framework for Evaluating Pharmacogenomics Knowledge for Personalized Medicine. Clin Pharmacol Ther. 2021 Sep;110(3):563-572. doi: 10.1002/cpt.2350. Epub 2021 Jul 22.
- Background: PubMed 37042794Ahire D, Heyward S, Prasad B. Intestinal Metabolism of Diclofenac by Polymorphic UGT2B17 Correlates with its Highly Variable Pharmacokinetics and Safety across Populations. Clin Pharmacol Ther. 2023 Jul;114(1):161-172. doi: 10.1002/cpt.2907. Epub 2023 Apr 29.
- Background: PubMed 18760392Xue Y, Sun D, Daly A, Yang F, Zhou X, Zhao M, Huang N, Zerjal T, Lee C, Carter NP, Hurles ME, Tyler-Smith C. Adaptive evolution of UGT2B17 copy-number variation. Am J Hum Genet. 2008 Sep;83(3):337-46. doi: 10.1016/j.ajhg.2008.08.004. Epub 2008 Aug 28.
- Background: PubMed 22669291Wang YH, Trucksis M, McElwee JJ, Wong PH, Maciolek C, Thompson CD, Prueksaritanont T, Garrett GC, Declercq R, Vets E, Willson KJ, Smith RC, Klappenbach JA, Opiteck GJ, Tsou JA, Gibson C, Laethem T, Panorchan P, Iwamoto M, Shaw PM, Wagner JA, Harrelson JC. UGT2B17 genetic polymorphisms dramatically affect the pharmacokinetics of MK-7246 in healthy subjects in a first-in-human study. Clin Pharmacol Ther. 2012 Jul;92(1):96-102. doi: 10.1038/clpt.2012.20. Epub 2012 Jun 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Diclofenac and curcumin in people with Interaction, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary F Paine, RPh, PhD (509-358-7759, mary.paine@wsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diclofenac area under the concentration vs. time curve (AUC) in UGT2B17 extensive metabolizers (EMs) (time frame: 0-12 hours). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053411, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.