NCT07348237 · Merck Sharp & Dohme LLC
A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)
What this study is about
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (how the drug moves through the body or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
View original scientific description
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
Interventions
DRUG
MK-2828
Oral administration
Primary outcome measures
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the AUC0-inf of MK-2828
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the AUC0-last of MK-2828
Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUC0-24 of MK-2828
Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Cmax of MK-2828
Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Tmax of MK-2828
Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma
Time frame: At designated time points up to 24 hours post dose
Blood samples will be collected to determine the C24 of MK-2828
Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the t1/2 of MK-2828
Apparent Total Plasma Clearance (CL/F) of MK-2828
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the CL/F of MK-2828
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma
Time frame: Pre dose and at designated time points up to 192 hours post dose
Blood samples will be collected to determine the Vz/F of MK-2828
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- include but are not limited to the following:
- Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor. Severe Renal Impairment Participants:
- Has an estimated glomerular filtration rate (eGFR) \< 30 mL/min), but is not on hemodialysis (HD) ESRD on HD Participants:
- Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for \> 3 months prior to study entry The main
Exclusion criteria
- include but are not limited to the following: Renal Impairment Participants:
- History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. Healthy Matched Control Participants:
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Where
- Miami Lakes, Florida
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations