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)

Launched by MERCK SHARP & DOHME LLC · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial, called MK-5684-010, is studying how a drug named MK-5684 behaves in the bodies of men who have severe kidney problems, including those with end-stage renal disease (ESRD), compared to healthy men. The main goal is to see how the drug levels change over time, especially after a treatment called hemodialysis, which is a common procedure for those with severe kidney impairment. Researchers want to understand these differences to help improve treatment for people with kidney issues.

To be eligible for the trial, participants need to be men aged 18 to 80 who are either healthy or have severe kidney impairment or ESRD. Participants with severe kidney impairment must have a specific measure of kidney function, while those with ESRD should be on a stable hemodialysis routine for at least three months. Throughout the study, participants will undergo various tests to monitor how their bodies process the drug. It's important to note that individuals with certain health conditions, like a history of heart issues or recent cancer, cannot participate. This study is currently recruiting participants, and those who join will contribute to important research that could lead to better treatments for kidney disease.

Gender

MALE

Eligibility criteria

• 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