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A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)

NCT ID: NCT06586671

Last Updated: 2024-09-19

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2023-11-13

Brief Summary

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The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.

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Detailed Description

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Conditions

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Hematological Malignancy

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 Form A

Participants receive nemtabrutinib form A orally.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral administration

Nemtabrutinib Form B

Participants receive nemtabrutinib form B orally.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral administration

Nemtabrutinib Form C

Participants receive nemtabrutinib form C orally.

Group Type EXPERIMENTAL

Nemtabrutinib

Intervention Type DRUG

Oral administration

Interventions

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Nemtabrutinib

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 before randomization
* Has a body mass index (BMI) ≥18 and ≤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 with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

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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QPS-MRA, LLC-Early Phase (Site 0002)

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-1026-007

Identifier Type: OTHER

Identifier Source: secondary_id

1026-007

Identifier Type: -

Identifier Source: org_study_id

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