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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States
Research by Design ( Site 0001)
Chicago, Illinois, United States
Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) After a Single Dose of MK-5684
Blood samples will be collected to determine the AUC0-inf of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Area Under the Concentration Versus Time Curve From 0 to the Time of the Last Quantifiable Sample (AUC0-last) of MK-5684
Blood samples will be collected to determine the AUC0-last of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Area Under the Concentration Versus Time Curve From 0 to 24 Hours After Dosing (AUC0-24) of MK-5684
Blood samples will be collected to determine the AUC0-24 of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 24 hours post-dose
Maximum Observed Drug Concentration (Cmax) After the Administration of a Given Dose of MK-5684
Blood samples will be collected to determine the Cmax of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Time to Maximum Observed Plasma Drug Concentration (Tmax) of MK-5684
Blood samples will be collected to determine the Tmax of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Terminal Half-Life (t½) of MK-5684
Blood samples will be collected to determine the t1/2 of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Clearance (CL/F) of MK-5684
Blood samples will be collected to determine the CL/F of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-5684
Blood samples will be collected to determine the Vz/F of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 72 hours post-dose
Number of Participants who Experience an Adverse Event (AE)
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.
Time frame: Up to ~21 days
Number of Participants who Discontinue Study Intervention Due to an AE
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.
Time frame: Up to ~7 days
Dialysis Clearance (CLD) of MK5684 Based on Plasma
Dialysate will be collected to determine the CLD of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Concentration of Dialysate (CD) of MK-5684 Samples
Dialysate will be collected to determine the CD of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose
Amount of drug (AD) of MK-5684 recovered from each dialysate collection
Dialysate will be collected to determine the AD of MK-5684 in plasma.
Time frame: At protocol specific time points pre-dose and up to 4.5 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.