Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to calderasib in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to compare the amount of calderasib when it is taken as a single dose; with multiple doses of itraconazole, or with multiple doses of phenytoin.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: \- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity After Single Dosing (AUC0-Inf) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the AUC0-Inf of calderasib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Sample (AUC0-last) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the AUC0-last of calderasib. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of Calderasib | Pre-dose and at designated time points up to 24 hours post dose | Blood samples will be collected to determine the AUC0-24 of calderasib. |
| Maximum Plasma Concentration (Cmax) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the Cmax of calderasib. |
| Plasma Concentration at 24 Hours (C24) of Calderasib | Pre-dose and at designated time points up to 24 hours post dose | Blood samples will be collected to determine the C24 of calderasib. |
| Time to Maximum Plasma Concentration (Tmax) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the Tmax of calderasib. |
| Apparent Terminal Half-life (t1/2) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the t1/2 of calderasib. |
| Apparent Clearance (CL/F) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the CL/F of calderasib. |
| Apparent volume of distribution during terminal phase (Vz/F) of Calderasib | Pre-dose and at designated time points up to 72 hours post dose | Blood samples will be collected to determine the Vz/F of calderasib. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 41 days | 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. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 25 days | 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. The number of participants who discontinue study treatment due to an AE will be reported. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed