A Study of the Effect of Nemtabrutinib (MK-1026) on the Plasma Levels of Digoxin in Healthy Participants (MK-1026-012)

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06625827
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Digoxin — DRUG
    Oral administration
  • Nemtabrutinib — DRUG
    Oral administration

Study Details

The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.

Key Dates

Start date
Nov 7, 2023
Status verified
Sep 2024
Primary completion
Jan 22, 2024
Completion
Jan 22, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Digoxin
    Participants receive a single oral dose of digoxin (Treatment A).
  • Experimental: Digoxin + Nemtabrutinib
    Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).

Primary Outcome Measure

Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin [ Time Frame: At designated timepoints (up to approximately 7 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
ICON (Site 0001)LenexaKansas66219-

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ICON· Lenexa, KS

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