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)
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
- Kidney Failure, Chronic
- End-Stage Kidney Disease
- Renal Failure, Chronic
- Renal Failure, End-Stage
- Healthy Participants
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
Arm | Description | Assigned 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). |
|
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. |
|
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). |
|
Recruiting Locations
Orlando, Florida 32809
Study Coordinator
888-577-8839
Chicago, Illinois 60643
Study Coordinator
888-577-8839
More Details
- NCT ID
- NCT06814132
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC