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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Belzutifan; Drug: Phenytoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06903715

6482-035

CA46602 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Belzutifan + Phenytoin

Experimental group

Description:

Participants receive belzutifan during study Period 1, followed by a washout period, then they receive belzutifan and phenytoin during study Period 2.

Treatment:

Drug: Phenytoin

Drug: Belzutifan