Belzutifan + Metformin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how the drug belzutifan affects the levels of metformin in healthy individuals. Participants will first take metformin alone, then take it again with belzutifan to observe changes in metformin's presence in the blood and urine. The trial seeks non-smokers who can swallow pills and have no recent history of cancer or specific blood or metabolic issues. 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 drug.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves taking metformin and belzutifan, it's best to discuss your current medications with the trial team to ensure there are no interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that belzutifan has been studied for conditions like kidney tumors. In these studies, belzutifan was generally well-tolerated, though some patients reported side effects such as tiredness and low red blood cell counts. It's important to note that these studies involved people with health conditions, not healthy volunteers.
Metformin is a medication commonly used to manage diabetes. It has a long history of safe use and is generally well-tolerated by most people. Some may experience mild side effects like an upset stomach, but these often decrease over time.
This is a Phase 1 trial, meaning researchers are primarily assessing the safety of these treatments in healthy people. This phase involves careful monitoring for any side effects. While belzutifan is not yet approved for use in healthy individuals, its use in other conditions provides some background on its safety. Metformin’s established safety record for diabetes offers reassurance about its use in this study.12345Why are researchers excited about this trial's treatments?
Researchers are excited about belzutifan combined with metformin because it offers a novel approach by targeting the HIF-2α pathway, which is different from the mechanisms of traditional treatments. Most treatments for conditions related to abnormal cellular oxygen sensing focus on other pathways or mechanisms. Belzutifan acts directly on the hypoxia-inducible factor (HIF) pathway, potentially offering new benefits in managing conditions like certain cancers or metabolic disorders. Additionally, the combination with metformin, a well-known diabetes medication, might enhance its effectiveness and provide broader therapeutic benefits. This dual action could lead to innovative strategies for tackling complex health issues more efficiently.
What evidence suggests that this trial's treatments could be effective?
Research has shown that belzutifan, a type of medication, produces promising results in treating certain rare tumors, with 26% of patients experiencing tumor shrinkage. Metformin, commonly used to control blood sugar, might enhance the effects of other treatments. Evidence suggests that combining metformin with other drugs can improve outcomes for cancers such as lung, colorectal, and prostate. In this trial, some participants will receive metformin alone, while others will receive a combination of belzutifan and metformin. Although the current study involves healthy participants, researchers are exploring the combination of belzutifan and metformin for potential benefits in various medical conditions.12467
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This clinical trial is for healthy adults who can safely take metformin and belzutifan. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be on conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1: Metformin Administration
Participants receive a single dose of metformin and pharmacokinetics are studied
Period 2: Belzutifan with Metformin
Belzutifan is administered daily for 5 days with a single dose of metformin on Day 4
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belzutifan
- Metformin
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