RECRUITING

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Open-Label Study to Assess the Pharmacokinetics of Mirdametinib and Its Metabolite PD-0315209 in Participants With Impaired Hepatic Function and Participants With Normal Hepatic Function

Quick Facts

Study Start:2025-05-07
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06997276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

SpringWorks Clinical
CONTACT
877-279-4870
clinical@springworkstx.com

Study Locations (Sites)

Clinical Pharmacology of Miami
Miami, Florida, 33014
United States
Orlando Clinical Research Center
Orlando, Florida, 32809
United States

Collaborators and Investigators

Sponsor: SpringWorks Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-05-07
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy
  • Hepatic Impairment