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

Merck Sharp & Dohme LLC14 enrolled

Overview

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

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BelzutifanDRUG

Oral administration

PhenytoinDRUG

Oral administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Celerion, Inc. ( Site 0001)

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Belzutifan

Blood samples will be collected to determine the AUC0-inf of belzutifan.

Time frame: Predose and at designated timepoints up to 120 hours postdose

Secondary Outcomes

Number of Participants Who Experience an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Time frame: Up to approximately 36 days

Number of Participants Who Discontinue Study Drug Due to an AE

Time frame: Up to approximately 22 days

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Belzutifan in Plasma

Blood samples will be collected to determine the AUC0-last of belzutifan.

Time frame: Predose and at designated timepoints up to 120 hours postdose

Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Belzutifan in Plasma

Blood samples will be collected to determine the AUC0-24 of belzutifan.

Time frame: Predose and at designated timepoints up to 24 hours postdose

Maximum Plasma Concentration (Cmax) of Belzutifan in Plasma

Blood samples will be collected to determine the Cmax of belzutifan.

Data from ClinicalTrials.gov

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