ClinicalTrials.gg
RecruitingNCT07840612Updated Nov 4, 2026

A Study to Assess the Effects of Probenecid on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

A Phase 1 interventional study of Mirdametinib and Probenecid in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (part of Merck KGaA, Darmstadt, Germany) · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 9, 2026Now RecruitingNewly registered+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a single-centre, open-label, fixed-sequence, 2-period study in healthy participants. The total study duration for each participant will be up to approximately 56 days, including a 28-day screening period, a 19-day assessment period (including Period 1 and Period 2), and a follow-up (FU) visit approximately 7 days after clinical research unit (CRU) discharge.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant has a 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 , aspartate aminotransferase, and total levels less than (\<) 1.5*the (ULN) at Screening.
  4. Participant has normal renal function as defined in the protocol.
  5. Participant must have no values outside the normal reference range of laboratory parameters for creatine phosphokinase (CPK), alkaline phosphatase (ALP), as well as leukocytes, neutrophils, and 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 (WOCBP). An additional form of 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 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

Exclusion Criteria:

  1. Participant has 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 , , or (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 (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 corrected by Fridericia's formula (QTcF) interval (>=450 milliseconds [msec]) or 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. \<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 , 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; within 28 days prior to Day 1.
    3. 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 to the study medications:

    1. Known 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.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
17 participants (estimated)

Study arms

  • Experimental
    Mirdametinib

    Drug: Mirdametinib

  • Experimental
    Mirdametinib and Probenecid

    Drug: Mirdametinib · Drug: Probenecid

Interventions

  • Mirdametinib capsules administered orally.

  • Probenecid tablets administered orally.

06

What researchers measure

Primary outcomes

  1. Geometric Mean Ratios of Mirdametinib Pharmacokinetic Plasma Concentration in Presence and Absence of Probenecid

    Time frame: Day 1 up to Day 26

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Screening up to Day 26

  2. Number of Participants with Clinically Significant Findings in Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs), Vital Signs, Ophthalmic and Physical Examinations

    Time frame: Screening up to Day 26

  3. Pharmacokinetic Plasma Concentration of Mirdametinib Alone and Following Probenecid

    Time frame: Day 1 up to Day 26

  4. Pharmacokinetic Plasma Concentration of Mirdametinib Metabolites Alone and Following Probenecid

    Time frame: Day 1 up to Day 26

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2026
First posted
Sep 25, 2026
StartActual
Sep 25, 2026
Primary completionEst.
Nov 17, 2026
CompletionEst.
Nov 17, 2026
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 9, 2026
Sites
1 site added, 1 site removed
Show site
  • Nuvisan GmbH · Neu-Ulm, Germany
Show 1 removed
  • Research Site · Darmstadt, Germany
Oct 9, 2026
Registered
First appeared on the registry
Sep 25, 2026
Show all 3 updates
  1. Nov 4, 2026
    Minor edits only
    + 1 other change: verification date
  2. Oct 9, 2026
    Not yet recruiting→Recruiting
    1 site added, 1 site removed
    Show site
    • Nuvisan GmbH · Neu-Ulm, Germany
    Show 1 removed
    • Research Site · Darmstadt, Germany
    + 3 other changes: verification date, date precision and references
  3. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07840612
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Sep 25, 2026
Primary completion
Nov 17, 2026 (estimated)
Completion
Nov 17, 2026 (estimated)
Last update
Nov 4, 2026

Study contacts

Communication Center
Contact
service@emdgroup.com
+49 6151 72 5200
Medical Responsible
study director · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Mirdametinib

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