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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2024-01-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Period 1: Nemtabrutinib

Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral administration

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.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral administration

Itraconazole

Intervention Type DRUG

Oral administration

Interventions

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Nemtabrutinib

Oral administration

Intervention Type DRUG

Itraconazole

Oral administration

Intervention Type DRUG

Other Intervention Names

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MK-1026 ARQ-531

Eligibility Criteria

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Inclusion Criteria

* 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

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes