MK-5684
DrugOral tablet
NCT Number: NCT06814132
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.
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Notify Me18 year–85 year
Male
Interventional
Phase 1
Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
include, but are not limited to:
All Participants
Participants with severe renal impairment (RI) (Group 1):
Participants with end-stage renal disease (ESRD) (Group 2):
Healthy Control Participants (Group 3):
Exclusion criteria
Exclusion criteria
include, but are not limited to:
All Participants:
Participants with Severe RI (Group 1):
Participants with ESRD (Group 2):
Oral tablet
Oral tablet
Other names: HRT
Oral tablet
Other names: HRT
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Merck Sharp & Dohme LLC
Industry
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-5684 in Male Participants With Severe Renal Impairment and With End-stage Renal Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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