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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Nemtabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06772818
1026-017
MK-1026-17 (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

20 patients

Sex

All

Ages

18 to 55 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 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

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)

20 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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