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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
Mirdametinib
DrugMirdametinib capsules administered orally.
Probenecid
DrugProbenecid tablets administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Geometric Mean Ratios of Mirdametinib Pharmacokinetic Plasma Concentration in Presence and Absence of Probenecid
Secondary outcomes
Number of Participants with Adverse Events (AEs)
Number of Participants with Clinically Significant Findings in Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs), Vital Signs, Ophthalmic and Physical Examinations
Pharmacokinetic Plasma Concentration of Mirdametinib Alone and Following Probenecid
Pharmacokinetic Plasma Concentration of Mirdametinib Metabolites Alone and Following Probenecid
Sponsors and contacts
Click on the lead sponsor to view all of their trials.