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)

NCT06814132 | Completed Phase 1 FDA Drug

• 3 other identifiers: 5684-010MK-5684-010CA43216
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Failure, Chronic; End-Stage Kidney Disease; Renal Failure, Chronic; Renal Failure, End-Stage; Healthy Participants

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Number of Participants who Experience an Adverse Event (AE)

  Up to ~21 days

• Number of Participants who Discontinue Study Intervention Due to an AE

  Up to ~7 days

• Dialysis Clearance (CLD) of MK5684 Based on Plasma

  At protocol specific time points pre-dose and up to 4.5 hours post-dose

• Concentration of Dialysate (CD) of MK-5684 Samples

  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

  At protocol specific time points pre-dose and up to 4.5 hours post-dose

Study Arms (3)

Group 1: Severe Renal Impairment (RI)

EXPERIMENTAL

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; Drug: Prednisone; Drug: Fludrocortisone acetate

Group 2: End-stage renal disease (ESRD)

EXPERIMENTAL

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; Drug: Prednisone; Drug: Fludrocortisone acetate

Group 3: Healthy Participants

EXPERIMENTAL

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; Drug: Prednisone; Drug: Fludrocortisone acetate

Interventions

MK-5684 DRUG

Oral tablet

Group 1: Severe Renal Impairment (RI); Group 2: End-stage renal disease (ESRD); Group 3: Healthy Participants

Prednisone DRUG

Oral tablet

Also known as: HRT

Group 1: Severe Renal Impairment (RI); Group 2: End-stage renal disease (ESRD); Group 3: Healthy Participants

Fludrocortisone acetate DRUG

Oral tablet

Also known as: HRT

Group 1: Severe Renal Impairment (RI); Group 2: End-stage renal disease (ESRD); Group 3: Healthy Participants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, 32809, United States

Location

Research by Design ( Site 0001)

Chicago, Illinois, 60643, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Prednisone; fludrocortisone acetate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 7, 2025
• Primary Completion: October 4, 2025
• Study Completion: October 14, 2025
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)