← Back to Search

HIF-2alpha Inhibitor

Belzutifan for Liver Impairment

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose
Awards & highlights

Study Summary

This trial will compare how well the body processes a new drug, belzutifan, in people with moderate liver impairment versus healthy people. It will also look at how safe and tolerable the drug is in people with moderate liver impairment.

Who is the study for?
This trial is for adults with stable moderate liver impairment and healthy individuals, both having a BMI of 18.0-40.0 kg/m². Women must be incapable of childbearing, while men should either practice abstinence or use contraception if sexually active with women who can bear children. Participants shouldn't have significant medical conditions, recent surgeries, drug abuse history, heavy nicotine/alcohol use, or certain vaccinations close to the study period.Check my eligibility
What is being tested?
The trial tests how a single dose of Belzutifan (80 mg) behaves in the bloodstream of people with moderate liver problems compared to healthy individuals. It also assesses the safety and tolerability of this medication in those with liver issues.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such trials monitor for any adverse reactions including but not limited to gastrointestinal symptoms, allergic reactions, changes in blood pressure or heart rate, headaches or dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to dose, and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 72, 96, and 120 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apparent terminal half-life (t½) of plasma concentration
Area under the plasma concentration time curve from hour 0 to 24 (AUC0-24)
Area under the plasma concentration time curve from hour 0 to infinity (AUC0-inf)
+2 more
Secondary outcome measures
Number of participants who discontinued from the study due to an AE
Number of participants who experienced an adverse event

Trial Design

2Treatment groups
Experimental Treatment
Group I: Belzutifan in participants with normal hepatic functionExperimental Treatment1 Intervention
Participants with normal hepatic function will receive a single oral 80 mg dose of belzutifan.
Group II: Belzutifan in participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single oral 80 mg dose of belzutifan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,805 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,554 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,463 Total Patients Enrolled

Media Library

Belzutifan (HIF-2alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04995484 — Phase 1
Liver Impairment Research Study Groups: Belzutifan in participants with normal hepatic function, Belzutifan in participants with moderate hepatic impairment
Liver Impairment Clinical Trial 2023: Belzutifan Highlights & Side Effects. Trial Name: NCT04995484 — Phase 1
Belzutifan (HIF-2alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995484 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum patient intake for this clinical trial?

"Correct. As per clinicaltrials.gov, this medical experiment is currently recruiting participants that were first posted on June 24th 2022 and recently modified on October 11th 2022. In order to complete the trial, 16 people need to be enlisted from 2 different sites."

Answered by AI

Are there opportunities still available to join this research project?

"According to clinicaltrials.gov, this research is actively recruiting patients and was initially posted on June 24th 2022. The trial's details were last updated on October 11th of the same year."

Answered by AI

Is Belzutifan deemed to be a safe medication for patients?

"Due to the limited evidence available, our team at Power have rated Belzutifan's safety as a 1 on their scale of 1-3. This is indicative of it being in Phase 1 trials with minimal data backing its efficacy and safety."

Answered by AI

Is this research study open to participants who are of age twenty and over?

"This experiment is targeting individuals who are between 18 and 75 years of age."

Answered by AI

May I be permitted to participate in this experiment?

"This clinical trial is accepting 16 patients with liver diseases between 18 and 75 years old."

Answered by AI

Could you list the previous research conducted with Belzutifan?

"Currently, 16 trials are running to explore the efficacy of Belzutifan. Of these studies, three have progressed to Phase 3. Most investigations take place in Cardiff, however there are 859 other sites that offer treatment with this drug."

Answered by AI

To what maladies is Belzutifan administered to address?

"Belzutifan is an approved therapeutic agent for treating malignant neoplasms, sickle cell anemia, and von Hippel Lindau disease."

Answered by AI

Is this clinical experiment a pioneering endeavor?

"Currently, Belzutifan is being trialled in 372 cities and 44 nations. Its first clinical trial was held by Peloton Therapeutics Incorporated back in 2016 with 120 participants; this Phase 1 study concluded successfully. Since then, one more research project has been conducted for the drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Belzutifan (MK-6482) Hepatic Impairment Study (MK-6482-020)
2022. "Belzutifan (MK-6482) Hepatic Impairment Study (MK-6482-020)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995484.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top