The purposes of this study are to determine:
* The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug. * How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function.
This study is for research purposes only and is not intended to treat any medical condition.
Participant understands the study procedures, is willing to comply with all study requirements and restrictions and agrees to participate in the study by providing written informed consent, prior to any study-related procedures being performed.
Participant is between 18 and 80 years of age (inclusive) at the time of informed consent.
Participant has a body mass index (BMI) ≥18 kg/m2 and ≤32 kg/m2 (inclusive) at Screening and Day -1 and a total body weight >50 kg.
Refrain from donating or preserving sperm; PLUS either
Participant is deemed unsuitable for this study in the opinion of the Investigator for any additional reason, condition, or prior therapy.
Participant has clinically significant infections (e.g., coronavirus disease 2019 [COVID-19] or influenza) within 90 days prior to Day 1, as judged by the Investigator, or evidence of any infection with the past 14 days prior to Day 1.
Participant has a history of stomach or gastrointestinal (GI) surgery or resection that would potentially alter absorption, metabolism, and/or excretion of PO administered drugs (exceptions include participants who underwent appendectomy, cholecystectomy, or any type of hernia repair).
Participant has a history of pre-existing condition (apart from hepatic impairment) interfering with normal GI anatomy or motility and potentially alter the absorption, metabolism, and/or excretion of orally administered drugs.
Sequential
Mirdametinib (MEK Inhibitor)
DrugMirdametinib will be administered as a single, oral, 4 mg dose in the morning on Day 1 for each study participant enrolled in the study.
Maximum plasma concentration (Cmax) of mirdametinib
Time of maximum observed concentration (Tmax) of mirdametinib
Area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf) of mirdametinib
Area under the concentration-time curve from dosing to time of last quantifiable concentration (AUClast) of mirdametinib
Safety and Tolerability of mirdametinib
Adverse events (AEs), clinical laboratory tests, 12-lead electrocardiograms (ECGs), vital signs, and physical examinations (PEs) will be assessed.
Maximum plasma concentration (Cmax) of PD-0315209
Time of maximum observed concentration (Tmax) of PD-0315209
Area under the concentration-time curve from dosing extrapolated to infinity (AUC0-inf) of PD-0315209
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