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Clinical Trial Details

Trial ID: L1241
Source ID: NCT06814132
Associated Drug: Mk-5684
Title: A Study to Evaluate the Effect of MK-5684 in Male Participants With Severe Renal Impairment (RI) and With End-stage Renal Disease (ESRD) (MK-5684-010)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|End-Stage Kidney Disease|Renal Failure, Chronic|Renal Failure, End-Stage|Healthy Participants
Interventions: DRUG: MK-5684|DRUG: Prednisone|DRUG: Fludrocortisone acetate
Outcome Measures: Primary: 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., 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., 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., 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., 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., 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., 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., 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., At protocol specific time points pre-dose and up to 72 hours post-dose | Secondary: 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., 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., 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., 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., 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., At protocol specific time points pre-dose and up to 4.5 hours post-dose
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2025-04-09
Completion Date: 2025-08-22
Results First Posted:
Last Update Posted: 2025-04-17
Locations: Orlando Clinical Research Center ( Site 0002), Orlando, Florida, 32809, United States|Research by Design ( Site 0001), Chicago, Illinois, 60643, United States
URL: https://clinicaltrials.gov/show/NCT06814132