Belzutifan Alone or With Phenytoin for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
Researchers designed belzutifan, the study medicine, to treat certain kinds of cancer.The goal of this study is to learn what happens to belzutifan in a healthy person's body over time when taken, by mouth, as a tablet. Researchers will learn what happens when belzutifan is taken alone and when it is taken after several days of treatment with phenytoin.
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.
What safety information is available for Belzutifan and Phenytoin in humans?
What makes the drug Belzutifan unique compared to other treatments?
Belzutifan is unique because it is being studied alone or in combination with phenytoin, which is traditionally used for seizures, suggesting a novel approach to treatment. This combination could potentially offer new insights into its effects and interactions, setting it apart from standard treatments.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