Mirdametinib for Liver Disease

Recruiting at 1 trial location

Overseen By SpringWorks Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SpringWorks Therapeutics, Inc.

Must not be taking: P-glycoprotein inhibitors

Disqualifiers: HIV, Cancer, GI surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 34

Duration: 8 days

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with moderate or severe liver impairment, as well as healthy volunteers to serve as a comparison group. Participants must be able to swallow pills and not have other significant medical conditions that could interfere with the study.

Inclusion Criteria

I have long-term, stable liver problems but am in good health otherwise.

I am not pregnant, using birth control, and agree to pregnancy tests.

I have good vein access in at least one arm for blood tests.

Exclusion Criteria

I have had a serious infection recently.

Participant is deemed unsuitable for the study by the Investigator for any additional reason, condition, or prior therapy

I don't have recent major surgeries, chronic bowel issues, recent cancer, severe acute illness, known allergies to study drugs, recent heavy alcohol use, or recent large blood donations. I'm willing to avoid certain activities and don't take excluded medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive mirdametinib to assess pharmacokinetics and tolerability

8 days

Multiple visits including D-1, D1, and D8/ET

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 days

Assessments up to 32 days post-dose

Treatment Details

Interventions

• Mirdametinib

Trial Overview The study is testing Mirdametinib, a MEK inhibitor drug, by comparing how individuals with different levels of liver function process it. It will look at the amount of drug in the blood over time and its breakdown products.

Participant Groups

Group I: Severe Hepatic Impairment Experimental Treatment 1 Intervention

Group II: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

Group III: Healthy Match Participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

SpringWorks Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

900+