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A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)

ClinicalTrials.gov Identifier: NCT06903715 (view full study on clinicaltrials.gov)
Condition:  Healthy
Status:  Completed


Official Title: An Open-Label, Phase 1 Study to Characterize the Effects of Phenytoin on the Pharmacokinetics of Belzutifan in Healthy Adult Participants

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.

Study Type:
Interventional
Study Phase:
Phase 1
Enrollment:
14
Study Start Date:
March 2025
Study Completion Date:
May 2025
Primary Completion Date:
May 2025
Ages Eligible for Study:
18 years to 60 years
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
Yes


CRITERIA

Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

  • Healthy, adult, male (vasectomized or surgically sterilized) or female (of non-childbearing potential)
  • Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study
  • History or presence of: Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI considers to be clinically significant; Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital); Depression, unusual changes in mood or behavior or suicidal thoughts and behavior; Hepatic porphyria (e.g., acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda)

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