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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1084-016 | Other Identifier | MSD |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin + metformin | Experimental | Participants will receive rosuvastatin plus metformin |
|
| Rosuvastatin + metformin + Calderasib | Experimental | Participants will receive rosuvastatin plus metformin plus calderasib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Rosuvastatin | Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Rosuvastatin | Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| AUC0-inf of Metformin | Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Rosuvastatin | Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| Area Under the Curve From Time 0 to 24 Hours (AUC0-24hrs) of Rosuvastatin |
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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 exclusion criteria include but are not limited to the following:
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| 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 |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Metformin | Drug | Oral tablet |
|
| Calderasib | Drug | Oral tablet |
|
|
Blood samples will be collected at multiple time points to estimate AUC0-24 |
| Day 1: Predose and at designated timepoints up to 24 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) of Rosuvastatin | Blood samples will be collected at multiple time points to estimate Tmax | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin | Blood samples will be collected at multiple time points to estimate t1/2 | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| Apparent Clearance (CL/F) of Rosuvastatin | Blood samples will be collected at multiple time points to estimate CL/F | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Rosuvastatin | Blood samples will be collected at multiple time points to estimate Vz/F | Day 1: Predose and at designated timepoints up to 120 hours post-dose |
| AUC0-last of Metformin | Blood samples will be collected at multiple time points to estimate AUC0-last | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| AUC0-24hrs of Metformin | Blood samples will be collected at multiple time points to estimate AUC0-24 | Day 1: Predose and at designated timepoints up to 24 hours post-dose |
| Cmax of Metformin | Blood samples will be collected at multiple time points to estimate Cmax | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Tmax of Metformin | Blood samples will be collected at multiple time points to estimate Tmax | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| t1/2 of Metformin | Blood samples will be collected at multiple time points to estimate t1/2 | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| CL/F of Metformin | Blood samples will be collected at multiple time points to estimate CL/F | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Vz/F of Metformin | Blood samples will be collected at multiple time points to estimate Vz/F | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| AUC0-inf of Calderasib | Blood samples will be collected at multiple time points to estimate AUC0-inf | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| AUC0-last of Calderasib | Blood samples will be collected at multiple time points to estimate AUC0-last | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| AUC0-24hrs of Calderasib | Blood samples will be collected at multiple time points to estimate AUC0-24 | Day 1: Predose and at designated timepoints up to 24 hours post-dose |
| Cmax of Calderasib | Blood samples will be collected at multiple time points to estimate Cmax | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Plasma Concentration at 24 Hours (C24) of Calderasib | Blood samples will be collected to estimate C24 | 24 hours post-dose |
| Tmax of Calderasib | Blood samples will be collected at multiple time points to estimate Tmax | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| t1/2 of Calderasib | Blood samples will be collected at multiple time points to estimate t1/2 | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| CL/F of Calderasib | Blood samples will be collected at multiple time points to estimate CL/F | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Vz/F of Calderasib | Blood samples will be collected at multiple time points to estimate Vz/F | Day 1: Predose and at designated timepoints up to 72 hours post-dose |
| Amount of Metformin Excreted Unchanged in Urine (Ae) | Urine samples will be collected at multiple time points to estimate Ae | Day 1: Predose and at designated timepoints up to 48 hours post-dose |
| Fraction of Metformin Excreted Unchanged in Urine (Fe) | Urine samples will be collected at multiple time points to estimate Fe | Day 1: Predose and at designated timepoints up to 48 hours post-dose |
| Renal Clearance of Metformin (CLr) | Urine samples will be collected at multiple time points to estimate CLr | Day 1: Predose and at designated timepoints up to 48 hours post-dose |
| Number of Participants Who Experience an Adverse Avent (AE) | 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. | Up to approximately 28 days after first dose |
| Number of Participants Who Discontinue Study Intervention Due to an AE | 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. | Up to approximately 14 days after first dose |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |