A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nemtabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06772805

1026-016

MK-1026-016 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria include, but are not limited to:

• Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed before randomization
• Has a body mass index (BMI) 18 to 32 kg/m^2 (inclusive)

Exclusion criteria

Exclusion criteria include, but are not limited to:

• 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Nemtabrutinib Treatment A

Experimental group

Description:

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

Treatment:

Drug: Nemtabrutinib

Nemtabrutinib Treatment B

Experimental group

Description:

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

Treatment:

Drug: Nemtabrutinib