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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin + MK-2828 | Experimental | Participants receive rosuvastatin and MK-2828 orally. |
|
| Furosemide + MK-2828 | Experimental | Participants receive furosemide and MK-2828 orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Oral administration |
| |
| Furosemide |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin | 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 | Blood samples will be collected to determine the AUC0-inf of furosemide. | At designated time points (up to approximately 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc ( Site 0001) | Daytona Beach | Florida | 32117 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Drug |
Oral administration |
|
| MK-2828 | Drug | Oral administration |
|
| Number of Participants Who Discontinue Study Treatment Due to an AE |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Blood samples will be collected to determine the Vz/F of furosemide. | At designated time points (up to approximately 2 weeks) |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |