A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009)

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06575933
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Calderasib — DRUG
    Oral administration
  • Midazolam — DRUG
    Oral administration
  • Digoxin — DRUG
    Oral administration

Study Details

The goal of the study is to see what happens to levels of midazolam and digoxin in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to midazolam and digoxin in the body when it is given with and without another medicine called calderasib. Researchers are testing if digoxin and midazolam levels in the body are different when digoxin and midazolam are given with or without calderasib.

Key Dates

Start date
Sep 3, 2024
Status verified
Feb 2026
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Period 1: Midazolam and Digoxin
    Participants will receive a single oral dose of midazolam and a single oral dose of digoxin on Day 1.
  • Experimental: Period 2: Calderasib, Midazolam, and Digoxin
    A washout period of at least 10 days will occur following midazolam and digoxin dosing in Period 1 and the first calderasib dosing in Period 2. Participants will receive calderasib once daily on Days 1 through Day 15 with a single oral dose of midazolam on Days 1, 6, and 14 and a single oral dose of digoxin on Days 1 and 11.

Primary Outcome Measure

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Midazolam [ Time Frame: Predose and at designated timepoints up to 24 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion ( Site 0001)TempeArizona85283-

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