Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
Male
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Orlando Clinical Research Center ( Site 0002)
Orlando, Florida 32809
Contact:
Study Coordinator
888-577-8839

Research by Design ( Site 0001)
Chicago, Illinois 60643
Contact:
Study Coordinator
888-577-8839

More Details

NCT ID
NCT06814132
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.