Healthy
Conditions
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.
Interventions
DRUGBelzutifan
Oral administration
DRUGPhenytoin
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Plasma Concentration 24 Hours Postdose (C24) of Belzutifan in Plasma | 24 hours postdose | Blood samples will be collected to determine the C24 of belzutifan. |
Countries
United States
Outcome results
None listed