Skip to main content
OpenTrials
Completed

NCT Number: NCT06903715

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc. ( Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Belzutifan

Drug

Oral administration

Other names: MK-6482, PT2977, Welireg™

Phenytoin

Drug

Oral administration

Other names: Phenytoin sodium

Primary outcomes

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

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

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

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Drug Due to an AE

    Time frame: 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.

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

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

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

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

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

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

  5. Maximum Plasma Concentration (Cmax) of Belzutifan in Plasma

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

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

  6. Plasma Concentration 24 Hours Postdose (C24) of Belzutifan in Plasma

    Time frame: 24 hours postdose

    Blood samples will be collected to determine the C24 of belzutifan.

  7. Time to Maximum Plasma Concentration (Tmax) of Belzutifan in Plasma

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

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

  8. Apparent Terminal Half-life (t1/2) of Belzutifan in Plasma

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

    Blood samples will be collected to determine the t1/2 of belzutifan.

  9. Apparent Clearance (CL/F) of Belzutifan in Plasma

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

    Blood samples will be collected to determine the CL/F of belzutifan.

  10. Apparent Volume of Distribution during terminal phase (Vz/F) of Belzutifan in Plasma

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

    Blood samples will be collected to determine the Vz/F of belzutifan.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Phase 1 Study to Characterize the Effects of Phenytoin on the Pharmacokinetics of Belzutifan in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.