Healthy
Conditions
Brief summary
Researchers want to learn about calderasib when given with rosuvastatin and metformin in healthy people. The goal of this study is to compare the amount of rosuvastatin and metformin in a person's body over time when given with and without calderasib
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: \- Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin |
| Maximum Plasma Concentration (Cmax) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to estimate Tmax |
| Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to estimate t1/2 |
| Apparent Clearance (CL/F) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to estimate CL/F |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to estimate Vz/F |
| AUC0-last of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-last |
| AUC0-24hrs of Metformin | Day 1: Predose and at designated timepoints up to 24 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-24 |
| Cmax of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Cmax |
| Tmax of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Tmax |
| t1/2 of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate t1/2 |
| CL/F of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate CL/F |
| Vz/F of Metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Vz/F |
| AUC0-inf of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-inf |
| AUC0-last of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-last |
| AUC0-24hrs of Calderasib | Day 1: Predose and at designated timepoints up to 24 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-24 |
| Cmax of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Cmax |
| Plasma Concentration at 24 Hours (C24) of Calderasib | 24 hours post-dose | Blood samples will be collected to estimate C24 |
| Tmax of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Tmax |
| t1/2 of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate t1/2 |
| CL/F of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate CL/F |
| Amount of Metformin Excreted Unchanged in Urine (Ae) | Day 1: Predose and at designated timepoints up to 48 hours post-dose | Urine samples will be collected at multiple time points to estimate Ae |
| Fraction of Metformin Excreted Unchanged in Urine (Fe) | Day 1: Predose and at designated timepoints up to 48 hours post-dose | Urine samples will be collected at multiple time points to estimate Fe |
| Renal Clearance of Metformin (CLr) | Day 1: Predose and at designated timepoints up to 48 hours post-dose | Urine samples will be collected at multiple time points to estimate CLr |
| Number of Participants Who Experience an Adverse Avent (AE) | Up to approximately 28 days after first dose | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported. |
| Vz/F of Calderasib | Day 1: Predose and at designated timepoints up to 72 hours post-dose | Blood samples will be collected at multiple time points to estimate Vz/F |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 14 days after first dose | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported. |
| Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose | Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin |
| Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin | Day 1: Predose and at designated timepoints up to 24 hours post-dose | Blood samples will be collected at multiple time points to estimate AUC0-24 |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed