Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-003 | Other Identifier | MSD |
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
The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of calderasib in a person's body over time.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calderasib Treatment A | Experimental | Participants will receive calderasib on Day 1 on an empty stomach |
|
| Calderasib Treatment B | Experimental | Participants will receive calderasib on Day 1 after a high-fat/high-calorie breakfast |
|
| Calderasib Treatment C | Experimental | Participants will receive calderasib Formulation 1 on Day 1 |
|
| Calderasib Treatment D | Experimental | Participants will receive calderasib Formulation 2 on Day 1 |
|
| Calderasib Treatment E | Experimental | Participants will receive calderasib without a PPI on Day 1 |
|
| Calderasib Treatment F | Experimental | Participants will receive calderasib with a PPI on Day 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calderasib | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Food effect: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: Maximum Plasma Concentration (Cmax) of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Area Under the Concentration-Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: AUC0-inf of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| Formulation Effect: Cmax of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Plasma Concentration at 24 hours (C24) of Calderasib |
| Measure | Description | Time Frame |
|---|---|---|
| Food Effect: AUC0-last of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: AUC0-24 of Calderasib |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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 (Site 0001) | Lincoln | Nebraska | 68502 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| PPI | Drug | Oral Capsule |
|
Blood samples will be collected to determine the C24 of calderasib. |
| 24 hours postdose |
| Formulation Effect: Lag Time (tlag) of Calderasib | Blood samples will be collected to determine the tlag of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Time to Maximum Plasma Concentration (Tmax) of Calderasib | Blood samples will be collected to determine the Tmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Apparent Terminal Half-Life (t1/2) of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Apparent Clearance (CL/F) of Calderasib | Blood samples will be collected to determine the CL/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Formulation Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Proton Pump Inhibitor (PPI) Effect: AUC0-inf of Calderasib | Blood samples will be collected to determine the AUC0-inf of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: Cmax of Calderasib | Blood samples will be collected to determine the Cmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
Blood samples will be collected to determine the AUC0-24 of calderasib.
| At designated timepoints (up to 24 hours postdose) |
| Food Effect: C24 of Calderasib | Blood samples will be collected to determine the C24 of calderasib. | 24 hours postdose |
| Food Effect: tlag of Calderasib | Blood samples will be collected to determine the tlag of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: Tmax of Calderasib | Blood samples will be collected to determine the Tmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: t1/2 of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: CL/F of Calderasib | Blood samples will be collected to determine the CL/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: Vz/F of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| Food Effect: Number of Participants Who Experience a Treatment Emergent Adverse Event (TEAE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |
| Food Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |
| Formulation Effect: Number of Participants Who Experience a TEAE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |
| Formulation Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |
| PPI Effect: AUC0-last of Calderasib | Blood samples will be collected to determine the AUC0-last of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: AUC0-24 of Calderasib | Blood samples will be collected to determine the AUC0-24 of calderasib. | At designated timepoints (up to 24 hours postdose) |
| PPI Effect: C24 of Calderasib | Blood samples will be collected to determine the C24 of calderasib. | 24 hours postdose |
| PPI Effect: tlag of Calderasib | Blood samples will be collected to determine the tlag of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: Tmax of Calderasib | Blood samples will be collected to determine the Tmax of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: t1/2 of Calderasib | Blood samples will be collected to determine the t1/2 of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: CL/F of Calderasib | Blood samples will be collected to determine the CL/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: Vz/F of Calderasib | Blood samples will be collected to determine the Vz/F of calderasib. | At designated timepoints (up to 48 hours postdose) |
| PPI Effect: Number of Participants Who Experience a TEAE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |
| PPI Effect: Number of Participants Who Discontinue Study Treatment Due to a TEAE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 2 months |