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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hematological Malignancy

Treatments: Drug: Nemtabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586671

MK-1026-007 (Other Identifier)

1026-007

Details and patient eligibility

About

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.

Enrollment: 40 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 before randomization
• Has a body mass index (BMI) ≥18 and ≤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 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Nemtabrutinib Form A

Experimental group

Description:

Participants receive nemtabrutinib form A orally.

Treatment:

Drug: Nemtabrutinib

Nemtabrutinib Form B

Experimental group

Description:

Participants receive nemtabrutinib form B orally.

Treatment:

Drug: Nemtabrutinib

Nemtabrutinib Form C

Experimental group

Description:

Participants receive nemtabrutinib form C orally.

Treatment:

Drug: Nemtabrutinib