A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)

Phase 1CompletedNCT07222098

Merck Sharp & Dohme LLC16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

RosuvastatinDRUG

Oral tablet

MetforminDRUG

Oral tablet

CalderasibDRUG

Oral tablet

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * Has history of cancer (malignancy) * Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Locations (1)

Celerion ( Site 0001)

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Day 1: Predose and at designated timepoints up to 72 hours post-dose

Secondary Outcomes

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

Time frame: 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

Blood samples will be collected at multiple time points to estimate AUC0-24

Time frame: 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

Time frame: Day 1: Predose and at designated timepoints up to 120 hours post-dose

Data from ClinicalTrials.gov

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Day 1: Apparent Terminal Half-life (t1/2) of Rosuvastatin

Blood samples will be collected at multiple time points to estimate t1/2

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 hours post-dose

Tmax of Calderasib

Blood samples will be collected at multiple time points to estimate Tmax

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to approximately 28 days after first dose

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 14 days after first dose