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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06903715

Run by

Merck Sharp & Dohme LLC

People needed

14

Starts

2025-03-28

Expected to finish

2025-05-27

Last updated by the study team

2025-06-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Celerion, Inc. ( Site 0001) — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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