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

ArmDescriptionAssigned Intervention
Experimental
Severe Renal Impairment
Participants with severe renal impairment will receive a single dose of MK-2828 on Day 1
  • Drug: MK-2828
    Oral administration
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.
  • Drug: MK-2828
    Oral administration
Experimental
Healthy Mean Matched Control
Participants with normal renal function will receive a single dose of MK-2828 on Day 1
  • Drug: MK-2828
    Oral administration

Recruiting Locations

Panax Clinical Research ( Site 0003)
Miami Lakes, Florida 33014
Contact:
Study Coordinator
305-698-4500

Floridian Clinical Research ( Site 0001)
Miami Lakes, Florida 33016
Contact:
Study Coordinator
305-330-9977

Orlando Clinical Research Center ( Site 0002)
Orlando, Florida 32809
Contact:
Study Coordinator
407-240-7878

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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