- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431866
A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)
A Two-Part Clinical Study to Evaluate the Effect of Multiple Doses of MK-2828 on Rosuvastatin (Part 1) and Furosemide (Part 2) in Healthy Participants
Researchers are looking for other ways to treat people who have heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart becomes stiff and does not relax properly. MK-2828 is a study medicine designed to treat HFpEF.
The main goal of the study is to learn if MK-2828 affects what happens to rosuvastatin or furosemide in the body.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Fortrea Clinical Research Unit Inc ( Site 0001)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rosuvastatin + MK-2828
Participants receive rosuvastatin and MK-2828 orally.
|
Oral administration
Oral administration
|
|
Experimental: Furosemide + MK-2828
Participants receive furosemide and MK-2828 orally.
|
Oral administration
Oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the AUC0-inf of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the AUC0-inf of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 1 month
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants who experience an AE will be reported.
|
Up to approximately 1 month
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 2 weeks
|
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants in who discontinue study treatment due to an AE will be reported.
|
Up to approximately 2 weeks
|
|
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the AUC0-last of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the AUC0-last of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
|
Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Rosuvastatin
Time Frame: At designated time points (up to approximately 24 hours)
|
Blood samples will be collected to determine the AUC0-24 of rosuvastatin.
|
At designated time points (up to approximately 24 hours)
|
|
Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Furosemide
Time Frame: At designated time points (up to approximately 24 hours)
|
Blood samples will be collected to determine the AUC0-24 of furosemide.
|
At designated time points (up to approximately 24 hours)
|
|
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Cmax of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Maximum Plasma Concentration (Cmax) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Cmax of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
|
Time of the Maximum Plasma Concentration (Tmax) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Tmax of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Time of the Maximum Plasma Concentration (Tmax) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Tmax of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
|
Terminal Half-life (t1/2) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the t1/2 of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Terminal Half-life (t1/2) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the t1/2 of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Total Plasma Clearance (CL/F) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the CL/F of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Total Plasma Clearance (CL/F) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the CL/F of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Rosuvastatin
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Vz/F of rosuvastatin.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Furosemide
Time Frame: At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the Vz/F of furosemide.
|
At designated time points (up to approximately 2 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2828-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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