Actively Recruiting
Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
Led by SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany · Updated on 2026-05-08
32
Participants Needed
3
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant understands the study procedures and agrees to participate by providing written consent.
- Participant is between 18 and 80 years old at consent.
- Participant has a body mass index (BMI) between 18 and 32 kg/m2 and a total body weight over 50 kg.
- Male participants agree to avoid sperm donation and either abstain from heterosexual intercourse or use condoms with additional contraception during treatment and for 90 days after.
- Female participants are not pregnant or breastfeeding and either are not of childbearing potential or agree to use contraception during treatment and for 90 days after.
- Female participants of childbearing potential and post-menopausal women must have a negative pregnancy test at screening and Day -1 unless surgically sterile.
- Participant has good venous access for blood sampling.
- Participants with hepatic impairment have stable chronic liver insufficiency for over 180 days, with no acute illness in the past 28 days.
- Concomitant medications must be stable for at least 28 days before dosing unless approved.
- Participants with hepatic impairment must have normal or mildly impaired kidney function.
- Participants must abstain from alcohol during the study and pass a negative breath alcohol test at screening and Day -1.
- Participants with hepatic impairment must meet criteria for moderate or severe impairment based on Child-Pugh classification within 28 days prior to dosing and at Day -1.
- Healthy control participants must be medically healthy with normal liver function tests and kidney function.
- Healthy controls must match paired hepatic impairment participants in age (within 10 years) and BMI (within 20%).
You will not qualify if you...
- Participant is unsuitable for study by investigator judgment.
- Participant has had significant infections like COVID-19 or influenza within 90 days, or any infection within 14 days prior to dosing.
- Participant with HIV positive test at screening.
- History of stomach or gastrointestinal surgery altering drug absorption, except appendectomy, gallbladder removal, or hernia repair.
- History of conditions affecting gastrointestinal anatomy or motility.
- History of inflammatory bowel disease, peptic ulcers, or pancreatitis within 180 days prior to dosing.
- History of cancer unless in remission for at least 5 years (except certain skin and prostate cancers).
- Acute illness requiring treatment within 14 days prior to dosing unless mild and approved.
- History of postural hypotension, unexplained fainting, or low blood pressure below 90/40 mmHg.
- Eye pressure above 21 mmHg or evidence of glaucoma or retinal vein occlusion.
- Known allergy or intolerance to study drug or excipients.
- Use of certain drug inhibitors within 14 days or 5 half-lives before dosing.
- Excessive alcohol intake in last 6 months.
- Consumption of poppy seeds within 72 hours prior to screening and Day -1.
- Blood donation or significant blood loss within 60 days or plasma donation within 7 days of screening.
- Received blood products within 60 days prior to screening.
- Unwillingness to avoid strenuous activity, sunbathing, or contact sports within 96 hours before admission until discharge.
- Abnormal QTcF interval above 450 msec on ECG at screening and Day -1.
- Participants with hepatic impairment cannot have Gilbert's syndrome, biliary sepsis within 2 years, portosystemic shunt, liver cancer, hepatorenal syndrome, or life expectancy under 1 year.
- No previous kidney, liver, or heart transplants.
- Recent gastrointestinal bleeding within 28 days prior to screening.
- Acute or worsening hepatitis or unstable liver function.
- Heart rate below 50 bpm or above 100 bpm after rest at screening and Day -1.
- History of right heart failure or uncontrolled ascites.
- Severe or uncontrolled high blood pressure.
- Healthy controls must have no clinically significant physical or laboratory abnormalities or liver disease.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
3
American Research Corporation (Texas Liver Institute)
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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