A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006)

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07348237
Phase
PHASE1
Status
Recruiting

Conditions

  • Chronic Kidney Failure
  • End-Stage Renal Disease
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
24 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • MK-2828 — DRUG
    Oral administration

Study Details

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.

Key Dates

Start date
Mar 2, 2026
Status verified
May 2026
Primary completion
Jul 20, 2026
Completion
Jul 20, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Floridian Clinical Research ( Site 0001)Miami LakesFlorida33016
Study Coordinator
305-330-9977
Panax Clinical Research ( Site 0003)Miami LakesFlorida33014
Study Coordinator
305-698-4500
Orlando Clinical Research Center ( Site 0002)OrlandoFlorida32809
Study Coordinator
407-240-7878

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