A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)
Purpose
The goal of this trial is to measure what happens to 1 or 2 doses of MK-2828 in a person's body over time (pharmacokinetic or PK trial). Researchers want to learn if the PK of people with certain types of kidney disease is similar to the PK of healthy people.
Conditions
- Chronic Kidney Failure
- End-Stage Renal Disease
- Renal Impairment
Eligibility
- Eligible Ages
- Between 24 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
include but are not limited to the following: - Is in generally good health, with the exception of renal impairment participants. Participants with stable, chronic medical or psychiatric conditions may be included at the discretion of the investigator and the Sponsor. Severe Renal Impairment Participants: - Has an estimated glomerular filtration rate (eGFR) < 30 mL/min), but is not on hemodialysis (HD) ESRD on HD Participants: - Has ESRD maintained on stable outpatient regimen of intermittent high-flux HD at a healthcare center for > 3 months prior to study entry The main
Exclusion Criteria
include but are not limited to the following: Renal Impairment Participants: - History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study. Healthy Matched Control Participants: - History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Severe Renal Impairment |
Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1 |
|
|
Experimental End Stage Renal Disease (ESRD) on Hemodialysis (HD) |
Participants with ESRD will receive a single dose of MK-2828 on Day 1 in each of 2 periods, with a washout of at least 14 days between doses. |
|
|
Experimental Healthy Mean Matched Control |
Participants with normal renal function will receive a single dose of MK-2828 on Day 1 |
|
Recruiting Locations
Miami Lakes, Florida 33014
Study Coordinator
305-698-4500
Miami Lakes, Florida 33016
Study Coordinator
305-330-9977
Orlando, Florida 32809
Study Coordinator
407-240-7878
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC