Bomedemstat for Hepatic Insufficiency
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how the drug bomedemstat (MK-3543) behaves in the body, particularly in individuals with liver problems. Researchers will compare the effects of a single dose in people with mild and moderate liver impairment to those in healthy individuals. This information could enhance understanding and treatment of liver conditions. Individuals with stable liver issues, who have not experienced severe liver-related problems recently, might qualify. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that bomedemstat is likely to be safe for humans?
Research has shown that bomedemstat is being tested for safety in people with liver problems. The FDA has granted bomedemstat special designations, such as Orphan Drug and Fast Track, for conditions like essential thrombocythemia (a blood disorder) and myelofibrosis (a bone marrow disorder). These designations indicate its promise in treating these conditions, which is encouraging.
In earlier studies, most participants tolerated bomedemstat well, experiencing no serious side effects. However, as this is still an early phase study, researchers continue to learn about its safety for people with liver issues.
For those considering joining a trial, this information may help in making an informed decision. However, keep in mind that the study is ongoing, and new findings may emerge.12345Why do researchers think this study treatment might be promising?
Bomedemstat is unique because it targets the LSD1 enzyme, which plays a role in regulating blood cell production and is implicated in liver disorders. Current treatments for hepatic insufficiency typically focus on managing symptoms and supporting liver function, but they don't address underlying biological pathways. Researchers are excited about bomedemstat because it offers a novel mechanism of action that could potentially modify the disease process itself, rather than just alleviating symptoms. Additionally, its oral administration makes it convenient for patients, which is always a plus in treatment compliance.
What evidence suggests that bomedemstat might be an effective treatment for hepatic insufficiency?
Research has shown that bomedemstat may help treat blood disorders like myelofibrosis. Early studies with patients found that bomedemstat can reduce the number of harmful blood cells, which helps lessen symptoms and might improve quality of life. Bomedemstat works by blocking LSD1, an enzyme involved in making certain blood cells. This unique mechanism might make it effective. However, this trial specifically aims to gather information on how well bomedemstat works for liver issues, such as liver impairment. Participants will include those with mild or moderate hepatic impairment, as well as healthy matched controls, all receiving a single oral 25 mg dose of bomedemstat.
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with chronic, stable liver insufficiency (cirrhosis) due to any cause. Participants must have a mild or moderate level of liver impairment based on the Child-Pugh scale and be non-smokers or moderate smokers. They should not have had acute illness from worsening hepatic function in the past 2 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of bomedemstat on Day 1
Pharmacokinetic Monitoring
Blood samples collected to determine pharmacokinetic parameters of bomedemstat
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bomedemstat (MK-3543)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University