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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Nemtabrutinib
Drug: Itraconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT06688045
1026-013
MK-1026-013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation.
  • Has a body mass index (BMI) of18 to 32 kg/m^2 (inclusive)

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Has a history of cancer (malignancy).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Period 1: Nemtabrutinib
Experimental group
Description:
Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.
Treatment:
Drug: Nemtabrutinib
Period 2: Nemtabrutinib + Itraconazole
Experimental group
Description:
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.
Treatment:
Drug: Itraconazole
Drug: Nemtabrutinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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