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

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)

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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