HealthyPhase 1NCT07431866
A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005)
A Phase 1 study testing Rosuvastatin, Furosemide and MK-2828 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rosuvastatin, Furosemide and MK-2828
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 13 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc ( Site 0001)
Daytona Beach, Florida, 32117
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Rosuvastatin, Furosemide, MK-2828
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Oral administration
FurosemideDrug
Oral administration
MK-2828Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin + MK-2828 | Experimental | Participants receive rosuvastatin and MK-2828 orally. Receives: Drug: Rosuvastatin; Drug: MK-2828 |
| Furosemide + MK-2828 | Experimental | Participants receive furosemide and MK-2828 orally. Receives: Drug: Furosemide; Drug: MK-2828 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At designated time points (up to approximately 2 weeks)
Secondary outcomes (16)
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.
Measured: Up to approximately 1 month
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At designated time points (up to approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start18 Mar 2026
- Primary completion13 Jun 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431866
- Sponsor's protocol ID
- 2828-005
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07431866
- Acronym / sponsor ID
- 2828-005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 13 Jun 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin + MK-2828 | Experimental | Drug: Rosuvastatin, Drug: MK-2828Participants receive rosuvastatin and MK-2828 orally. |
| Furosemide + MK-2828 | Experimental | Drug: Furosemide, Drug: MK-2828Participants receive furosemide and MK-2828 orally. |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Has a body mass index (BMI) ≥18 and ≤32 kg/m^2
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinOral administration | Drug | Rosuvastatin + MK-2828 |
| FurosemideOral administration | Drug | Furosemide + MK-2828 |
| MK-2828Oral administration | Drug | Furosemide + MK-2828, Rosuvastatin + MK-2828 |
Primary outcome
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.
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.
16 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 1 month
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: 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)
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)
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)
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)
Maximum Plasma Concentration (Cmax) of Rosuvastatin
Time frame: 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)
Time of the Maximum Plasma Concentration (Tmax) of Rosuvastatin
Time frame: 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)
Terminal Half-life (t1/2) of Rosuvastatin
Time frame: 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)
Apparent Total Plasma Clearance (CL/F) of Rosuvastatin
Time frame: 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)
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Rosuvastatin
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin, Furosemide and MK-2828 in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.