Belzutifan Alone or With Phenytoin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how belzutifan, a medication designed for certain cancers, behaves in the body of a healthy person when taken as a tablet. Researchers will study the effects of belzutifan both alone and after several days of taking phenytoin, a medication used to control seizures. Participants should be healthy adults who are either vasectomized men or women who cannot become pregnant, with a BMI between 18 and 32.
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 medication.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves healthy participants and tests interactions with phenytoin, it's possible that you may need to stop other medications. Please consult with the study team for specific guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that belzutifan generally has a manageable safety profile. In earlier studies, nearly all participants (99.3%) experienced some side effects. More serious side effects occurred in about 61.6% of participants, and 41.0% faced very serious side effects. These serious issues included anemia (low red blood cell count), hypoxia (low oxygen levels), and retinal detachment (an eye problem).
When taken with phenytoin, belzutifan can be processed faster by the body, potentially altering its effectiveness and safety. However, specific information about side effects when these two drugs are used together is not available.
As this trial is in the early stages, it primarily focuses on understanding how the drug works in the body, resulting in limited information on its long-term safety. Nonetheless, belzutifan is already approved for some cancers, providing some confidence about its safety in humans. Always consult a healthcare provider before deciding to join a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about belzutifan because it represents a novel approach to treatment by targeting hypoxia-inducible factor 2-alpha (HIF-2α), a protein involved in cancer growth and survival. Unlike traditional treatments that often target the tumor directly, belzutifan disrupts the cancer's adaptation to low-oxygen environments, which can inhibit tumor growth. This unique mechanism of action offers potential for effectiveness in cases where standard treatments, such as chemotherapy or targeted therapies, might not be sufficient.
What evidence suggests that belzutifan might be an effective treatment for cancer?
Research has shown that belzutifan may help treat certain cancers. In studies with patients who have von Hippel-Lindau (VHL) disease, almost two-thirds experienced tumor reduction, indicating that belzutifan can effectively reduce tumor size. Another study found that 64% of patients had stable cancer without progression. These results strongly suggest that belzutifan could be effective in treating cancer. In this trial, participants will receive belzutifan alone during one period and belzutifan combined with phenytoin during another period to evaluate the effects in healthy subjects.678910
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 healthy adults who are either vasectomized men or non-childbearing potential women with a BMI between 18.0 and 32.0 kg/m2. It's not specified, but typically participants should have no significant health issues.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive belzutifan alone to assess pharmacokinetics
Washout
A washout period to clear belzutifan from the body before the next treatment phase
Treatment Period 2
Participants receive belzutifan with phenytoin to assess interaction effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Belzutifan
- Phenytoin
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