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)

NCT ID: NCT06814132

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2025-10-14

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

MK-5684

Intervention Type: DRUG

Oral tablet

Prednisone

Intervention Type: DRUG

Oral tablet

Fludrocortisone acetate

Intervention Type: DRUG

Oral tablet

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.

Group Type: EXPERIMENTAL

MK-5684

Intervention Type: DRUG

Oral tablet

Prednisone

Intervention Type: DRUG

Oral tablet

Fludrocortisone acetate

Intervention Type: DRUG

Oral tablet

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).

Group Type: EXPERIMENTAL

MK-5684

Intervention Type: DRUG

Oral tablet

Prednisone

Intervention Type: DRUG

Oral tablet

Fludrocortisone acetate

Intervention Type: DRUG

Oral tablet

Interventions

MK-5684

Oral tablet

Intervention Type: DRUG

Prednisone

Oral tablet

Intervention Type: DRUG

Fludrocortisone acetate

Oral tablet

Intervention Type: DRUG

Other Intervention Names

HRT; HRT

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, United States

Research by Design ( Site 0001)

Chicago, Illinois, United States

Countries

United States

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-5684-010

Identifier Type: OTHER

Identifier Source: secondary_id

CA43216

Identifier Type: OTHER

Identifier Source: secondary_id

5684-010

Identifier Type: -

Identifier Source: org_study_id