A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06688045
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Nemtabrutinib — DRUG
    Oral administration
  • Itraconazole — DRUG
    Oral administration

Study Details

The goal of this study is to learn what happens to levels of nemtabrutinib in a person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called itraconazole.

Key Dates

Start date
Oct 30, 2023
Status verified
Oct 2024
Primary completion
Jan 6, 2024
Completion
Jan 6, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Period 1: Nemtabrutinib
    Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.
  • Experimental: Period 2: Nemtabrutinib + Itraconazole
    Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4.

Primary Outcome Measure

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib [ Time Frame: At designated time points (up to approximately 10 days postdose) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research Unit Inc. (Site 0001)HonoluluHawaii96813-

Find similar trials in Honolulu, HI

By research site
Labcorp Clinical Research Unit Inc.· Honolulu, HI

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