Chronic Kidney Failure, End-Stage Renal Disease, Renal Impairment
Conditions
Brief summary
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
DRUGMK-2828
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
The main 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 14 days | 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. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 2 days | 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. The number of participants who experience an AE will be reported. |
| Area Under the Concentration-time Curve From Start to End of Dialysis (AUCD) of MK-2828 | Prior to hemodialysis (HD) and at designated time points until day 6 | Blood samples will be collected to determine the AUCD of MK-2828 |
| Area Under the Concentration-time Curve Determined from the Pre-dialyzer Line (AUCCa) of MK-2828 | Prior to hemodialysis (HD) and at designated time points until day 6 | Blood samples will be collected to determine the during AUCCa of MK-2828 during the dialysis period |
| Area Under the Concentration-time Curve Determined from the Post-dialyzer Line (AUCCv) of MK-2828 | Prior to hemodialysis (HD) and at designated time points until day 6 | Blood samples will be collected to determine the during AUCCv of MK-2828 during the dialysis period |
| Dialysis Clearance (CLD) of MK-2828 Based on Plasma | Prior to hemodialysis (HD) and at designated time points until day 6 | Blood samples will be collected to determine the CLD of MK-2828 based on plasma during the dialysis period |
| Hemodialysis Extraction Ratio (ER_D) of MK-2828 | Prior to hemodialysis (HD) and at designated time points until day 6 | Blood samples will be collected to determine the ER\_D of MK-2828 during the dialysis period |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed