Can a gout drug change how the body handles a cancer treatment?

NCT ID NCT07840612

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether probenecid, a medicine used for gout, affects how the body breaks down mirdametinib, an experimental cancer drug. The study enrolls about 17 healthy volunteers who take mirdametinib alone and then with probenecid. By measuring drug levels in the blood, the team aims to understand whether the two drugs interact, which could help guide safer dosing in future cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirdametinib, an experimental cancer drug, given with probenecid, a gout medicine used here to block a liver enzyme
What this could lead to
If probenecid changes how the body handles mirdametinib, researchers could learn how to adjust doses or avoid interactions when patients take both types of drugs.
What could go wrong
This is a small, early-stage study in healthy people, not patients with cancer. The results may not predict what happens in people who are sick or taking other medicines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 17 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant has a body mass index greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilograms per meter square (kg/m\^²) (inclusive) at Screening. 2. Participant is in good health in the judgement of the investigator on the basis of a medical evaluation performed at Screening, Day -1, and predose on Day 1, and the results of clinical chemistry, haematology, and urinalysis tests carried out at Screening and Day -1. 3. Participant has alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels less than (\<) 1.5\*the upper limit of normal (ULN) at Screening. 4. Participant has normal renal function as defined in the protocol. 5. Participant must have no clinically significant values outside the normal reference range of laboratory parameters for creatine phosphokinase (CPK), alkaline phosphatase (ALP), as well as leukocytes, neutrophils, and hemoglobin in the opinion of the investigator. 6. Participant has sufficiently good venous access in at least 1 arm to confidently enable serial blood sampling. 7. Male participants who agree to the following during study and for at least 90 days after the last dose of study medication: 1. Refrain from donating or preserving sperm, PLUS either 2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, OR 3. Must agree to use a male condom when having sexual intercourse with women of childbearing potential (WOCBP). An additional form of contraception as described in the protocol should also be used by the female partner if she is of childbearing potential. Refer to protocol for definition of WOCBP. 8. Female participants that are not pregnant or breastfeeding, and for whom one of the following conditions applies: a. Is a woman of non-childbearing potential, as defined in the protocol, OR 9. Is a WOCBP and agrees to use a highly effective contraceptive method as described in the protocol from the time of signed informed consent and for at least 6 months after the last dose of study medication (noting that a barrier method must be used in addition to systemically acting hormonal contraceptives); AND a. All female participants must have a negative serum pregnancy test at Screening and CRU admission (Day -1). Exclusion Criteria: 1. Participant has clinically significant infections (e.g., coronavirus disease \[COVID\] or influenza) within 90 days prior to Day 1, as judged by the investigator, or evidence of any infection within 14 days prior to Day 1. If a participant tests positive (reactive) for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at Screening, they are not eligible for participation in the study. 2. Participant has a history of stomach or gastrointestinal (GI) surgery or resection that would potentially alter absorption, metabolism, and/or excretion of oral (PO) drugs (exceptions include participants who underwent appendectomy or any type of hernia repair). 3. Participant has a history of a pre-existing condition interfering with normal GI anatomy or motility and potentially altering the absorption, metabolism, and/or excretion of PO drugs. 4. Participant has Gilbert's syndrome. 5. Participant has a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within 180 days prior to Day 1. 6. Participant has a history of cancer, except if judged to be in full remission for at least 5 years at the time of informed consent (except basal cell skin cancer, resected prostate cancer with an undetectable prostate-specific antigen test, undetectable cervical cancer, or squamous cell skin cancer with history of curative treatment and no recurrence for at least 3 years prior to Screening), as judged by the investigator. 7. Participant has an acute illness with symptoms or treatment that has started or persisted within 14 days prior to Day 1 unless mild in severity and enrolment is approved by both the investigator and the sponsor's medical monitor. 8. Participant has any evidence of glaucoma or retinal pathology at Screening or an intraocular pressure (IOP) \>21 millimeters of mercury \[mmHg\] at Day -1. 9. Participant has any cardiovascular abnormalities including: 1. History of postural hypotension, unexplained syncope, or abnormal autonomic tone. 2. Blood pressure \<90/50 mmHg or \>=140/90 mmHg after 5 minutes of rest. 3. Pulse rate \<50 or \>90 bpm after 5 minutes of rest. 4. Abnormal QT interval corrected by Fridericia's formula (QTcF) interval (\>=450 milliseconds \[msec\]) or ECG abnormalities interfering with QT/QTc interpretation, QRS complex \>=120 msec, risk factors for torsades de pointes, or any other clinically relevant abnormalities as judged by investigator. 5. History of congestive heart failure. 6. Ejection fraction \<55%. 10. Participant has an acute urinary infection or incomplete bladder emptying (voiding \>2 times/night). 11. Participant has substance use concerns: 1. Positive alcohol, cotinine, or drug screen test. 2. Consumption of an average weekly alcohol intake of \>14 units/week for men or \>7 units/week for women. One unit (12 grams \[g\]) of alcohol equals one-half pint (285 milliliters \[mL\]) of beer or lager, 1 glass (125 mL) of wine, or one-sixth gill (25 mL) of spirits 3. Tobacco or nicotine use within 3 months prior to Screening 12. Excessive consumption of xanthine-containing food or beverages (\>400 milligrams per day \[mg/day\]). a. Unwillingness to avoid xanthine-containing products 72 hours before dosing until after collection of the final PK sample 13. Participant has taken, received, or consumed: 1. Any prescription medications, over-the-counter medications, supplements, or herbal products, with exception of paracetamol/acetaminophen hormonal contraception, within 14 days or 5 half-lives if known (whichever is longer) prior to Day 1. 2. Vaccines within 14 days prior to Day 1; live vaccines within 28 days prior to Day 1. 3. Investigational products within 28 days or 5 half-lives (whichever is longer), or \>3 new investigational entities within 12 months prior to Day 1 4. Red wine, fruit or fruit juices (including, but not limited to, grapefruit, grapefruit juice, pomelos, or other exotic citrus fruits or grapefruit hybrids), or any nutrients known to modulate drug metabolising enzyme/transporters activity (including, but not limited to, cranberries or star fruits) within 72 hours of Day 1 as outlined in the protocol. 14. Participant has donated blood (\>450 mL) within 60 days, donated plasma within 7 days, or received blood products within 60 days prior to Screening. 15. Participant is unwilling to avoid strenuous activity, sunbathing, or contact sports during the study. 16. Participant has specific contraindications to the study medications: 1. Known hypersensitivity to probenecid, mirdametinib, or related compounds, including ingredients. 2. History of anaphylaxis or any other significant allergic reactions. 3. History or presence of any clinically significant haematologic condition. 4. Other contraindications including cross reactivities listed in the probenecid SmPC 17. Participant is deemed unsuitable for this study in the opinion of the investigator for any additional reason.

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As listed by the trial registrant

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How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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Contacts and locations

Locations

  • Research Site

    Darmstadt, Germany

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