Status:
COMPLETED
A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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, b...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06903715
Start Date
March 28 2025
End Date
May 27 2025
Last Update
June 13 2025
Active Locations (1)
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1
Celerion, Inc. ( Site 0001)
Tempe, Arizona, United States, 85283