Actively Recruiting
An Open-Label, Single-Dose Study to Evaluate MK-2828 Pharmacokinetics in People With Renal Impairment
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-02
24
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, or how the body processes, of one or two doses of the drug MK-2828 in people with kidney disease. The study aims to determine if the way MK-2828 behaves in individuals with certain types of kidney impairment is similar to that in healthy people. This research is a Phase 1 clinical trial focusing on participants with severe renal impairment, end-stage renal disease (ESRD), and healthy controls. Participants with severe renal impairment will receive a single oral dose of MK-2828 on Day 1. Those with ESRD on hemodialysis will receive a single dose in each of two study periods, separated by at least 14 days. Healthy participants with normal kidney function will receive a single dose on Day 1. The trial is open-label, meaning all participants and researchers know which treatment is given. During the study, participants will have blood samples collected before dosing and at various times up to 192 hours afterward to measure drug levels and related pharmacokinetic parameters. Those on hemodialysis will have additional assessments related to dialysis clearance. Safety will be monitored through tracking adverse events up to approximately 14 days. The study will continue until July 2026, with participants involved in a single-dose administration and follow-up sampling and observation.
CONDITIONS
Brief Title
A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be generally in good health except for renal impairment
- Participants with severe renal impairment must have an estimated glomerular filtration rate (eGFR) less than 30 mL/min and not be on hemodialysis
- Participants with end-stage renal disease (ESRD) must be on stable outpatient intermittent high-flux hemodialysis for more than 3 months prior to study entry
- Adults aged 24 to 85 years old
You will not qualify if you...
- Participants with renal impairment who have any other illness that could affect study results or pose additional risks
- Healthy matched control participants with significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological diseases
- Participants with a recent history of complicated medical events that might interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 6 days including dosing and monitoring
Participants receive a single dose of MK-2828. Those with end-stage renal disease on hemodialysis receive two doses separated by at least 14 days.
1 to 2 dosing visits and multiple follow-up visits for up to 6 days
Duration - Up to approximately 14 days
Participants are monitored for safety and adverse events up to approximately 14 days after dosing.
Multiple visits or contacts up to 14 days post dosing
Trial Site Locations
Total: 3 locations
1
Panax Clinical Research ( Site 0003)
Miami Lakes, Florida, United States, 33014
Actively Recruiting
2
Floridian Clinical Research ( Site 0001)
Miami Lakes, Florida, United States, 33016
Actively Recruiting
3
Orlando Clinical Research Center ( Site 0002)
Orlando, Florida, United States, 32809
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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