Evaluating MK-5684 in men with severe kidney impairment and end-stage renal disease

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

This study tests how the drug MK-5684 works in men with severe kidney problems and end-stage renal disease compared to healthy men.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Merck Sharp & Dohme LLC (industry)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT06814132 on ClinicalTrials.gov

What this trial studies

This study aims to assess how MK-5684 behaves in the bodies of male participants with severe renal impairment and end-stage renal disease compared to healthy individuals. Researchers will monitor the drug's levels over time, particularly after hemodialysis sessions. The study will include participants with varying degrees of kidney function to understand the drug's pharmacokinetics in these populations.

Who should consider this trial

Good fit: Ideal candidates include male participants with severe renal impairment or end-stage renal disease who are undergoing hemodialysis.

Not a fit: Patients with normal kidney function or those not meeting the specific renal impairment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with severe renal impairment and end-stage renal disease.

How similar studies have performed: Other studies have explored pharmacokinetics in renal impairment, but this specific approach with MK-5684 is novel.

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

Where this trial is running

Orlando, Florida and 1 other locations

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

Study contacts

• Study coordinator: Toll Free Number

Conditions: Kidney Failure, Chronic, End-Stage Kidney Disease, Renal Failure, Chronic, Renal Failure, End-Stage, Healthy Participants