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)
Status and phase
Enrolling
Phase 1
Conditions
End-Stage Kidney Disease
Healthy Participants
Renal Failure, End-Stage
Renal Failure, Chronic
Kidney Failure, Chronic
Treatments
Drug: Prednisone
Drug: Fludrocortisone acetate
Drug: MK-5684
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
24 estimated patients
Sex
Male
Ages
18 to 85 years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
24 participants in 3 patient groups
Group 1: Severe Renal Impairment (RI)
Experimental group
Description:
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).
Treatment:
Drug: MK-5684
Drug: Fludrocortisone acetate
Drug: Prednisone
Group 2: End-stage renal disease (ESRD)
Experimental group
Description:
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.
Treatment:
Drug: MK-5684
Drug: Fludrocortisone acetate
Drug: Prednisone
Group 3: Healthy Participants
Experimental group
Description:
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).
Treatment:
Drug: MK-5684
Drug: Fludrocortisone acetate
Drug: Prednisone
Trial contacts and locations
2
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Central trial contact
Toll Free Number
Data sourced from clinicaltrials.gov
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