A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06698016
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Nemtabrutinib — DRUG
    Oral administration
  • Efavirenz — DRUG
    Oral administration

Study Details

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy 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 efavirenz.

Key Dates

Start date
Jul 25, 2023
Status verified
Nov 2024
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023

Study Design

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

Arms

  • Experimental: Period 1: Nemtabrutinib
    Participants receive a single dose of nemtabrutinib followed by a protocol specified wash-out period.
  • Experimental: Period 2: Nemtabrutinib + Efavirenz
    Participants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11.

Primary Outcome Measure

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib [ Time Frame: Predose and at designated time points (up to 2 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Kansas, Inc. (Site 0001)Overland ParkKansas66212-

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Altasciences Clinical Kansas, Inc.· Overland Park, KS

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