A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-017)

NCT ID: NCT06772818

Last Updated: 2025-01-14

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2024-02-16

Brief Summary

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The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nemtabrutinib Treatment A

Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast)

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral Tablet

Nemtabrutinib Treatment B

Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal)

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral Tablet

Interventions

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Nemtabrutinib

Oral Tablet

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 signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
* Has a body mass index (BMI) 18.0 to 32.0 kg/m\^2 (inclusive)

Exclusion Criteria

* Has a history of clinically significant endocrine, gastrointestinal, 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

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Labcorp Clinical Research Unit Inc. (Site 0001)

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-1026-17

Identifier Type: OTHER

Identifier Source: secondary_id

1026-017

Identifier Type: -

Identifier Source: org_study_id

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