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)

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

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 Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; End-Stage Kidney Disease; Healthy Participants; Renal Failure, Chronic; Renal Failure, End-Stage
• Intervention / Treatment: Drug: MK-5684; Drug: Prednisone; Drug: Fludrocortisone acetate

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center ( Site 0002)
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research by Design ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

All Participants:

• Has a history or presence of any of the following: Adrenal insufficiency; Hepatic impairment; Clinically significant hypotension; cardiac arrhythmia; cardiac conduction abnormalities or recurrent unexplained syncopal events; Second- or third-degree atrioventricular (AV) heart block (except in participants with a functional artificial pacemaker); Clinically significant sick sinus syndrome; Any systemic fungal infection; Hypothyroidism; Chronic infection
• Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest, or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome (including Brugada syndrome)
• Has a history of cancer (malignancy)
• Is positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Participants with Severe RI (Group 1):

• Has a history or presence of renal artery stenosis
• Has had a renal transplant
• Has ESRD requiring HD

Participants with ESRD (Group 2):

• Has required frequent emergent HD (≥ 3) within a year prior to the first dosing
• Has a history or presence of renal artery stenosis.
• Has had a functioning renal transplant within the past 2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Severe Renal Impairment (RI); Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).	Drug: MK-5684; Oral tablet; Drug: Prednisone; Oral tablet; Other Names: HRT; Drug: Fludrocortisone acetate; Oral tablet; Other Names: HRT
Experimental: Group 2: End-stage renal disease (ESRD); Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) in Period 1 and Period 2. In Period 1, participants will receive a single oral dose of MK-5684 approximately 30 minutes prior to their normally scheduled hemodialysis (HD), followed by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing. In Period 2, participants will receive a single oral dose of MK-5684 immediately followed by completion of their normally scheduled HD, and by HRT under fed conditions (eating a normal meal) 4.5 hours after MK-5684 dosing.	Drug: MK-5684; Oral tablet; Drug: Prednisone; Oral tablet; Other Names: HRT; Drug: Fludrocortisone acetate; Oral tablet; Other Names: HRT
Experimental: Group 3: Healthy Participants; Participants will receive a single oral dose of MK-5684 under fasting conditions (on an empty stomach after a 10-hour overnight fast) on Day 1 and a single dose of Hormone replacement therapy (HRT) (prednisone and fludrocortisone) administered approximately 4.5 hours after MK-5684 dosing under fed conditions (eating a normal meal).	Drug: MK-5684; Oral tablet; Drug: Prednisone; Oral tablet; Other Names: HRT; Drug: Fludrocortisone acetate; Oral tablet; Other Names: HRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Actual): October 4, 2025
• Study Completion (Actual): October 14, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): February 7, 2025

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Prednisone; fludrocortisone acetate
• Other Study ID Numbers: 5684-010; MK-5684-010 (Other Identifier: MSD); CA43216 (Other Identifier: Celerion)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No