A Clinical Study of MK-1084 With Rosuvastatin and Metformin in Healthy People (MK-1084-016)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT07222098
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers want to learn about MK-1084 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 MK-1084
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 16
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
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Rosuvastatin + metformin + MK-1084 MK-1084 Participants will receive rosuvastatin plus metformin plus MK-1084 Rosuvastatin + metformin + MK-1084 Rosuvastatin Participants will receive rosuvastatin plus metformin plus MK-1084 Rosuvastatin + metformin Rosuvastatin Participants will receive rosuvastatin plus metformin Rosuvastatin + metformin Metformin Participants will receive rosuvastatin plus metformin Rosuvastatin + metformin + MK-1084 Metformin Participants will receive rosuvastatin plus metformin plus MK-1084
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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 MK-1084 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 MK-1084 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 MK-1084 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
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
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
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
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
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
Cmax of MK-1084 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
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
Plasma Concentration at 24 Hours (C24) of MK-1084 24 hours post-dose Blood samples will be collected to estimate C24
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
Tmax of MK-1084 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 MK-1084 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
CL/F of MK-1084 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 MK-1084 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
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.
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.