14 Participants Needed

Belzutifan Alone or With Phenytoin for Healthy Subjects

TF
Overseen ByToll Free Number
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Phenytoin, used for epilepsy, can cause side effects like sleepiness, gum overgrowth, and coordination problems. Some people may also experience skin reactions, especially if they have certain genetic traits. There is no specific safety data available for Belzutifan in the provided research.12345

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

What data supports the effectiveness of the drug Phenytoin?

Phenytoin has been shown to be effective in managing seizures, as it was compared with other drugs like valproate and levetiracetam in treating pediatric convulsive status epilepticus, a severe form of epilepsy.911121314

Who Is on the Research Team?

MD

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

My BMI is between 18.0 and 32.0.
I am an adult who cannot have children, either through surgery or naturally.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive belzutifan alone to assess pharmacokinetics

7 days
Daily visits for blood sampling

Washout

A washout period to clear belzutifan from the body before the next treatment phase

7 days

Treatment Period 2

Participants receive belzutifan with phenytoin to assess interaction effects

7 days
Daily visits for blood sampling

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Belzutifan
  • Phenytoin
Trial Overview The study is testing belzutifan, a new cancer treatment drug, to see how it behaves in the body when taken alone or combined with phenytoin, an existing medication. Participants will take belzutifan orally as a tablet over time.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Belzutifan + PhenytoinExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Citations

Clinical experience with lamotrigine monotherapy in adults with newly diagnosed epilepsy: a review of published randomised clinical trials. [2021]
Association of lamotrigine and valproate in refractory epilepsies of children and adolescents. [2019]
Comparison of Phenytoin, Valproate and Levetiracetam in Pediatric Convulsive Status Epilepticus: A Randomized Double-blind Controlled Clinical Trial. [2021]
A survey of lamotrigine and vigabatrin treatment in children with severe epilepsy. [2019]
Combination therapy in epilepsy: when and what to use. [2022]
Phenobarbitone versus phenytoin monotherapy for epilepsy: an individual participant data review. [2022]
Adverse reactions to antiepileptic drugs: a multicenter survey of clinical practice. Collaborative Group for Epidemiology of Epilepsy. [2019]
Associations of CYP2C9 and CYP2C19 Pharmacogenetic Variation with Phenytoin-Induced Cutaneous Adverse Drug Reactions. [2021]
Phenytoin revisited. [2013]
Adverse effects of carbamazepine, phenytoin, valproate and lamotrigine monotherapy in epileptic adult Chinese patients. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Risk factors of early adverse drug reactions with phenytoin: A prospective inpatient cohort. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Intravenous phenytoin in acute treatment of seizures. [2019]
Lack of pharmacokinetic interaction between zileuton and phenytoin in humans. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
A Review of Phenytoin Monotherapy in Adults With Nonrefractory Status Epilepticus. [2021]
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.
Terms of Service·Privacy Policy·Cookies·Security