A Clinical Study of Calderasib (MK-1084) in Participants With Renal Impairment (MK-1084-010)

Part of paid clinical trials in Orlando, Florida.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06814119
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The goal of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to people with moderate or severe renal impairment (RI) (meaning the kidneys do not work properly) as compared to people who are in good health. Researchers also want to learn about the safety of calderasib when it is given to people with RI and if people with RI can tolerate it.

Key Dates

Start date
Apr 7, 2025
Status verified
Feb 2026
Primary completion
Jan 23, 2026
Completion
Feb 6, 2026

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Panel A: Severe RI
    Participants with severe RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.
  • Experimental: Panel B: Moderate RI
    Participants with moderate RI will be administered a single oral dose of calderasib on Day 1 under fasting conditions.
  • Experimental: Panel C: Healthy
    Healthy participants will be administered a single oral dose of calderasib on Day 1 under fasting conditions.

Primary Outcome Measure

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of calderasib [ Time Frame: At designated timepoints (up to approximately 2 days postdose) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando Clinical Research Center ( Site 0002)OrlandoFlorida32809-
Research by Design ( Site 0001)ChicagoIllinois60643-

Find similar trials in Orlando, FL

By research site
Orlando Clinical Research Center· Orlando, FLResearch by Design· Chicago, IL

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