Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CA46602 | Other Identifier | Celerion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belzutifan + Phenytoin | Experimental | Participants receive belzutifan during study Period 1, followed by a washout period, then they receive belzutifan and phenytoin during study Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belzutifan | Drug | Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Belzutifan | Blood samples will be collected to determine the AUC0-inf of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 36 days |
Not provided
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. ( Site 0001) | Tempe | Arizona | 85283 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000720612 | belzutifan |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phenytoin | Drug | Oral administration |
|
|
| Number of Participants Who Discontinue Study Drug Due to an AE |
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. |
| Up to approximately 22 days |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Belzutifan in Plasma | Blood samples will be collected to determine the AUC0-last of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24) of Belzutifan in Plasma | Blood samples will be collected to determine the AUC0-24 of belzutifan. | Predose and at designated timepoints up to 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of Belzutifan in Plasma | Blood samples will be collected to determine the Cmax of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Plasma Concentration 24 Hours Postdose (C24) of Belzutifan in Plasma | Blood samples will be collected to determine the C24 of belzutifan. | 24 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of Belzutifan in Plasma | Blood samples will be collected to determine the Tmax of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Apparent Terminal Half-life (t1/2) of Belzutifan in Plasma | Blood samples will be collected to determine the t1/2 of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Apparent Clearance (CL/F) of Belzutifan in Plasma | Blood samples will be collected to determine the CL/F of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Apparent Volume of Distribution during terminal phase (Vz/F) of Belzutifan in Plasma | Blood samples will be collected to determine the Vz/F of belzutifan. | Predose and at designated timepoints up to 120 hours postdose |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |