Healthy
Conditions
Brief summary
This study has 2 parts. Researchers want to learn what happens to calderasib in a healthy person's body over time in both parts. The goals of the study are: * In Part 1, to compare what happens to calderasib in a person's blood when it is taken as 2 different types of oral tablets * In Part 2, to learn what happens to calderasib in a person's blood when it is taken on an empty stomach or after a meal
Interventions
DRUGCalderasib OCT
Oral tablet
DRUGCalderasib FCT
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: \- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the AUC0-last of calderasib. |
| Parts 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the AUC0-inf of calderasib. |
| Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of calderasib. |
| Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Cmax of calderasib. |
| Parts 1 and 2: Plasma Concentration of Calderasib at 24 Hours Postdose (C24) | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the C24 of calderasib. |
| Parts 1 and 2: Time to Maximum Plasma Concentration (Tmax) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Tmax of calderasib. |
| Parts 1 and 2: Apparent Terminal Half-life (t1/2) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the t1/2 of calderasib. |
| Parts 1 and 2: Apparent Clearance (CL/F) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the CL/F of calderasib. |
| Parts 1 and 2: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the Vz/F of calderasib. |
| Part 2: Plasma Lag Time (tlag) of Calderasib | At designated timepoints (up to approximately 2 days postdose) | Blood samples will be collected to determine the tlag of calderasib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 7 weeks | An AE is any untoward medical occurrence in a clinical study 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 |
| Parts 1 and 2: Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 1 week | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue from the study treatment due to an AE will be reported. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed