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

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Mirdametinib

    Drug

    Mirdametinib capsules administered orally.

  • Probenecid

    Drug

    Probenecid tablets administered orally.

Treatment groups

17 Participants
are divided into 2 treatment groups
Group A: MirdametinibExperimental treatment 1 intervention
Group B: Mirdametinib and ProbenecidExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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