Clinical trial NCT06903715: A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)
Official title: An Open-Label, Phase 1 Study to Characterize the Effects of Phenytoin on the Pharmacokinetics of Belzutifan in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Belzutifan
timeFrame: Predose and at designated timepoints up to 120 hours postdose
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 36 days
measure: Number of Participants Who Discontinue Study Drug Due to an AE
timeFrame: Up to approximately 22 days
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 24 hours postdose
measure: Maximum Plasma Concentration (Cmax) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Plasma Concentration 24 Hours Postdose (C24) of Belzutifan in Plasma
timeFrame: 24 hours postdose
measure: Time to Maximum Plasma Concentration (Tmax) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Apparent Terminal Half-life (t1/2) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Apparent Clearance (CL/F) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
measure: Apparent Volume of Distribution during terminal phase (Vz/F) of Belzutifan in Plasma
timeFrame: Predose and at designated timepoints up to 120 hours postdose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc. ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: