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HealthyPhase 1NCT07840612

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

A Phase 1 study testing Mirdametinib and Probenecid in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Mirdametinib and Probenecid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteGermany
Study dates
25 Sep 2026to 17 Nov 2026
Phase
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

  • 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.
  • 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.
  • Participant has alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels less than (<) 1.5*the upper limit of normal (ULN) at Screening.
  • Participant has normal renal function as defined in the protocol.
  • 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.
  • Participant has sufficiently good venous access in at least 1 arm to confidently enable serial blood sampling.
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  • Male participants who agree to the following during study and for at least 90 days after the last dose of study medication:
  • Refrain from donating or preserving sperm, PLUS either
  • 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
  • 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.
  • Female participants that are not pregnant or breastfeeding, and for whom one of the following conditions applies:
  • Is a woman of non-childbearing potential, as defined in the protocol, OR
  • 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).

Who cannot join

  • 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.
  • 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).
  • 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.
  • Participant has Gilbert's syndrome.
  • Participant has a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within 180 days prior to Day 1.
  • 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.
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  • 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.
  • Participant has any evidence of glaucoma or retinal pathology at Screening or an intraocular pressure (IOP) >21 millimeters of mercury [mmHg] at Day -1.
  • Participant has any cardiovascular abnormalities including:
  • History of postural hypotension, unexplained syncope, or abnormal autonomic tone.
  • Blood pressure <90/50 mmHg or >=140/90 mmHg after 5 minutes of rest.
  • Pulse rate <50 or >90 bpm after 5 minutes of rest.
  • 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.
  • History of congestive heart failure.
  • Ejection fraction <55%.
  • Participant has an acute urinary infection or incomplete bladder emptying (voiding >2 times/night).
  • Participant has substance use concerns:
  • Positive alcohol, cotinine, or drug screen test.
  • 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
  • Tobacco or nicotine use within 3 months prior to Screening
  • Excessive consumption of xanthine-containing food or beverages (>400 milligrams per day [mg/day]).
  • Unwillingness to avoid xanthine-containing products 72 hours before dosing until after collection of the final PK sample
  • Participant has taken, received, or consumed:
  • 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.
  • Vaccines within 14 days prior to Day 1; live vaccines within 28 days prior to Day 1.
  • Investigational products within 28 days or 5 half-lives (whichever is longer), or >3 new investigational entities within 12 months prior to Day 1
  • 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.
  • Participant has donated blood (>450 mL) within 60 days, donated plasma within 7 days, or received blood products within 60 days prior to Screening.
  • Participant is unwilling to avoid strenuous activity, sunbathing, or contact sports during the study.
  • Participant has specific contraindications to the study medications:
  • Known hypersensitivity to probenecid, mirdametinib, or related compounds, including ingredients.
  • History of anaphylaxis or any other significant allergic reactions.
  • History or presence of any clinically significant haematologic condition.
  • Other contraindications including cross reactivities listed in the probenecid SmPC
  • Participant is deemed unsuitable for this study in the opinion of the investigator for any additional reason.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Communication Center contact

+49 6151 72 5200

service@emdgroup.com

Germany1 site, 1 recruiting

  • Nuvisan GmbH

    Neu-Ulm, 89231

    lyubov.chernaya@nuvisan.com

    Lyubov Chernaya

    Recruiting

Other trials in Germany

About this study

Official title: A Phase 1, Open-Label, Drug Interaction Study to Assess the Effects of Probenecid, a Probe UGT Enzyme Inhibitor, on the Pharmacokinetics of Mirdametinib and Its Metabolites in Healthy Participants

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.

Conditions
Healthy
Being tested
Mirdametinib, Probenecid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirdametinibDrug

    Mirdametinib capsules administered orally.

  • ProbenecidDrug

    Probenecid tablets administered orally.

Study groups in NCT07840612
Study groupRoleWhat they receive
MirdametinibExperimentalNot described
Receives: Drug: Mirdametinib
Mirdametinib and ProbenecidExperimentalNot described
Receives: Drug: Mirdametinib; Drug: Probenecid

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 up to Day 26

Secondary outcomes (4)

  1. Number of Participants with Adverse Events (AEs)

    Measured: 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

    Measured: Screening up to Day 26

  3. Pharmacokinetic Plasma Concentration of Mirdametinib Alone and Following Probenecid

    Measured: Day 1 up to Day 26

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

    Measured: Day 1 up to Day 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start25 Sep 2026
  3. Primary completion17 Nov 2026 (estimated)
  4. Study completion17 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840612
Sponsor's protocol ID
MEK-NF1-106
Other IDs
2026-526403-30-00
Status last verified
Nov 2026
First submitted
18 Sep 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mirdametinib and Probenecid in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

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 13 inclusion and 35 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 4 Nov 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 Germany. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Communication Center (+49 6151 72 5200, service@emdgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Ratios of Mirdametinib Pharmacokinetic Plasma Concentration in Presence and Absence of Probenecid (time frame: Day 1 up to Day 26). 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 NCT07840612.

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 4 Nov 2026.

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