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

Phase 1

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: Belzutifan; Drug: Phenytoin

• Registration Number: NCT06903715
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-01
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-05-08
• Study Completion: 2025-05-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Belzutifan + Phenytoin	Belzutifan	Participants receive belzutifan during study Period 1, followed by a washout period, then they receive belzutifan and phenytoin during study Period 2.
Belzutifan + Phenytoin	Phenytoin	Participants receive belzutifan during study Period 1, followed by a washout period, then they receive belzutifan and phenytoin during study Period 2.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Belzutifan	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the AUC0-inf of belzutifan.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 36 days	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.
Number of Participants Who Discontinue Study Drug Due to an AE	Up to approximately 22 days	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 discontinue study due to an AE will be reported.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the AUC0-last of belzutifan.
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Belzutifan in Plasma	Predose and at designated timepoints up to 24 hours postdose	Blood samples will be collected to determine the AUC0-24 of belzutifan.
Maximum Plasma Concentration (Cmax) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the Cmax of belzutifan.
Plasma Concentration 24 Hours Postdose (C24) of Belzutifan in Plasma	24 hours postdose	Blood samples will be collected to determine the C24 of belzutifan.
Time to Maximum Plasma Concentration (Tmax) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the Tmax of belzutifan.
Apparent Terminal Half-life (t1/2) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the t1/2 of belzutifan.
Apparent Clearance (CL/F) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the CL/F of belzutifan.
Apparent Volume of Distribution during terminal phase (Vz/F) of Belzutifan in Plasma	Predose and at designated timepoints up to 120 hours postdose	Blood samples will be collected to determine the Vz/F of belzutifan.

Trial Locations

Locations (1)

Celerion, Inc. ( Site 0001); 🇺🇸 Tempe, Arizona, United States