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Official title Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
ClinicalTrials.gov ID: NCT06997276
What this study is testing
What is Mirdametinib (MEK Inhibitor)?
Mirdametinib (MEK Inhibitor) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Also referred to as PD-0325901.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- (All Participants):
- Participant understands the study procedures, is willing to comply with all study requirements and restrictions and agrees to participate in the...
- 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.
- Male participants that agree to the following during the treatment periods and for at least 90 days after the last dose of study treatment:
You likely can't join if
- (All Participants):
- 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...
- Participant has a history of stomach or gastrointestinal (GI) surgery or resection that would potentially alter absorption, metabolism, and/or...
- Participant has a history of pre-existing condition (apart from hepatic impairment) interfering with normal GI anatomy or motility and potentially...
- Participants with a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within the 180 days prior to Day 1.
See the full eligibility criteria
Who can join
- (All Participants):
- 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...
- 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.
- Male participants that agree to the following during the treatment periods and for at least 90 days after the last dose of study treatment:
- 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 Appendix 4 of the protocol should also be used by the...
- Female participants that are not pregnant or breastfeeding, and for whom one of the following conditions applies:
- Refrain from donating or preserving eggs for at least 90 days after the last dose of study treatment PLUS either
- Is a woman of non-childbearing potential, as defined in Appendix 4 OR
- Is a WOCBP and agrees to use an acceptable contraceptive method as described in Appendix 4 from the time of informed consent and for at least 90 days after the last dose of study treatment; AND
- WOCBP and post-menopausal women must have a negative serum pregnancy test at Screening and on CRU admission on Day -1 unless confirmed as surgically sterile.
- Participant has sufficiently good venous access in at least one arm to confidently enable serial blood sampling. (Participants with Hepatic Impairment):
- Participant has chronic (\>180 days), stable hepatic insufficiency, with no acute episodes of illness or liver injury within 28 days prior to Screening due to deterioration in hepatic function and must remain stable...
- Concomitant medications for the management of an individual participant's medical history should be stable for at least 28 days prior to dose of study treatment. On a case-by-case basis, with approval from the Sponsor...
- Aside from hepatic impairment, the participant must, in the opinion of the Investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, 12-lead...
- Participant has normal or mildly impaired renal function as evidenced by estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (i.e., ≥...
- Participant is willing and able to abstain from alcohol throughout the duration of the study (from Screening to FU phone call) and has a negative breath alcohol test at Screening and CRU admission (Day -1).
- Participant may be enrolled if the criteria for moderate hepatic impairment based on Child-Pugh Classification Class B (Cohort 1) or severe hepatic impairment based on Child-Pugh Classification C (Cohort 3) is satisfied...
- Participant is considered to be medically healthy, as determined by a responsible and experienced Investigator, based on a clinical evaluation (including medical history, physical examination, clinical laboratory tests...
- Participant is considered to be without hepatic disease and has normal hepatic function at screening and check-in (serum bilirubin, serum albumin, and international normalized ratio [INR]). Participants may be included...
- If these tests are out of range, one laboratory repeat will be allowed at screening and upon check-in on Day -1.
- Participant's age at Screening must be within 10 years of the Day -1 age for the intended paired participant.
- Participant's BMI at Screening must be within 20% of the Day -1 BMI for the intended paired participant.
- Participant has normal renal function as evidenced by eGFR as calculated by the CKD-EPI creatinine formula (i.e., ≥ 60 mL/min/1.73 m2) or local standard.
What rules you out
- (All Participants):
- 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...
- 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...
- 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...
- Participants with a history of inflammatory bowel disease, peptic ulceration, or pancreatitis within the 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 PSA, or...
- Participant has an acute illness with symptom or treatment that has started or persisted within 14 days prior to study treatment administration unless mild in severity and enrollment is approved by both Investigator and...
- Participant has a history of postural hypotension, unexplained syncope, or a Day -1 blood pressure (BP) that is less than 90 mmHg systolic or 40 mmHg diastolic.
- Participant has intraocular pressure (IOP) \>21 mmHg or any evidence of glaucoma or retinal vein occlusion at Screening or Day -1.
- Participant has a known hypersensitivity or intolerance to any of the study treatments, or excipients thereof, or a history of drug or other allergy that, in the opinion of the Investigator or Sponsor medical monitor...
- Participant has received any P-glycoprotein or breast cancer resistance protein inhibitors within 14 days or 5 half-lives (whichever is longer) prior to Day 1. See Appendix 5 for examples of these agents.
- Participant has a history of excessive intake of alcohol, defined as an average daily intake of greater than 3 units, or an average weekly intake of greater than 14 units (one unit is equivalent to one can or bottle...
- Participant has consumed food containing poppy seeds within 72 hours of Screening and Day -1 as outlined in Section 5.3.1.
- Participant has donated blood or had a loss of more than 450 mL of blood within 60 days or donation of plasma within 7 days prior to Screening.
- Participant has received blood products within the 60 days prior to Screening.
- Participant is unwilling to avoid strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours prior to admission to the CRU and until discharge from the CRU.
- Participant has abnormal QT interval corrected by Fridericia's formula (QTcF), defined as \>450 msec (single ECG) at Screening and Day -1.
- If the ECG shows an abnormal QTcF, repeat the ECG after 30 minutes to determine whether the finding is confirmed. Exclusion Criteria (Participants with Hepatic Impairment):
- Participant has a history of Gilbert's syndrome, history of biliary sepsis within the past 2years, or a portosystemic shunt.
- Participant has hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).
- Participant has previously received a transplanted kidney, liver, or heart.
- Participant has history of GI hemorrhage due to esophageal varices or peptic ulcers less than 28 days prior to Screening.
- Participant has acute or exacerbating hepatitis, fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment in the...
- NOTE: Participants with previously treated Hepatitis B, who have had a non-detectable viral load for at least 6 months prior to Day 1, and are considered clinically stable by the Investigator, may be considered for...
- Participant has heart rate (HR) that is \ 100 bpm after resting in a supine position for 5 minutes at Screening and Day -1.
- Participant has history of right heart failure or uncontrolled ascites.
- Participant has persistent severe or uncontrolled hypertension, i.e., supine BP
- 150 mmHg (systolic) or ≥100 mmHg (diastolic), following at least 5 minutes of supine rest. If repeated measures are needed for confirmation, two additional measurements should be taken and the average of three...
- Participant has evidence of a clinically significant deviation from normal in the physical examination, vital signs, ECG readings, or clinical laboratory determinations at Screening and Day -1.
- Participant has evidence of clinically significant hepatic illness or abnormalities.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Orlando, Florida, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Orlando, Florida, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.