Recruiting
Phase 1

MK-2828

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07348237

Conditions

Chronic Kidney Failure

End-Stage Renal Disease

Renal Impairment

Eligibility Criteria

Sex: All

Age: 24 - 70+

Healthy Volunteers: Accepted

Interventions

MK-2828

Study Details

Brief summary:

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

Study ID

NCT07348237

Start date

Mar 2, 2026

Status verified date

Aug, 2026

Completion date

Sep 21, 2026

Anticipated

Primary completion date

Sep 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 24 - 70+

Healthy Volunteers: Accepted

The main 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

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

MK-2828

Oral administration

Primary outcome measure

  • Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 24 hours post dose ]
  • Maximum Plasma Concentration (Cmax) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Time of the Maximum Observed Concentration (Tmax) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Concentration at 24 Hours Postdose (C24) of MK-2828 in Plasma [ Time Frame: At designated time points up to 24 hours post dose ]
  • Apparent Terminal Elimination Half-life (t1/2) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Apparent Total Plasma Clearance (CL/F) of MK-2828 [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]
  • Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of MK-2828 in Plasma [ Time Frame: Pre dose and at designated time points up to 192 hours post dose ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Panax Clinical Research ( Site 0003)

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Study Coordinator

305-698-4500

Floridian Clinical Research ( Site 0001)

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

Study Coordinator

305-330-9977

Orlando Clinical Research Center ( Site 0002)

Recruiting

Orlando, Florida, United States, 32809

Contacts

Study Coordinator

407-240-7878

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-14.