Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage, Healthy Participants
Conditions
Brief summary
The goal of the study is to learn what happens to levels of MK-5684 in people with severe renal impairment and end-stage renal disease versus a healthy person's body over time. Researchers will compare what happens to MK-5684 after hemodialysis in people with severe renal impairment and end-stage renal disease versus healthy people.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include, but are not limited to: All Participants * Is a continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to the first dosing * Has a body mass index (BMI) ≥ 18.0 and ≤ 42.0 kg/m\^2 at the screening visit Participants with severe renal impairment (RI) (Group 1): * Has severely impaired renal function as determined by estimated glomerular filtration rate (eGFR) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation Participants with end-stage renal disease (ESRD) (Group 2): * Has ESRD maintained on stable outpatient regimen of intermittent high-flux hemodialysis (HD) (at least 3 times per week) for a minimum of 3 hours per dialysis session, using a complication free well-maintained arteriovenous fistula or arteriovenous graft, for at least 3 months prior to first dosing and is expected and planning to continue HD during the study and at least up to the follow-up visit Healthy Control Participants (Group 3): * Has normal renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the Vz/F of MK-5684 in plasma. |
| Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684 | At protocol specific time points pre-dose and up to 24 hours post-dose | Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma. |
| Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the Cmax of MK-5684 in plasma. |
| Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the Tmax of MK-5684 in plasma. |
| Apparent Terminal Half-Life (t½) of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the t1/2 of MK-5684 in plasma. |
| Apparent Clearance (CL/F) of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the CL/F of MK-5684 in plasma. |
| Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma. |
| Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684 | At protocol specific time points pre-dose and up to 72 hours post-dose | Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Discontinue Study Intervention Due to an AE | Up to ~7 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Dialysis Clearance (CLD) of MK5684 Based on Plasma | At protocol specific time points pre-dose and up to 4.5 hours post-dose | Dialysate will be collected to determine the CLD of MK-5684 in plasma. |
| Concentration of Dialysate (CD) of MK-5684 Samples | At protocol specific time points pre-dose and up to 4.5 hours post-dose | Dialysate will be collected to determine the CD of MK-5684 in plasma. |
| Amount of drug (AD) of MK-5684 recovered from each dialysate collection | At protocol specific time points pre-dose and up to 4.5 hours post-dose | Dialysate will be collected to determine the AD of MK-5684 in plasma. |
| Number of Participants who Experience an Adverse Event (AE) | Up to ~21 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
Countries
United States
Outcome results
None listed