Clinical trial NCT06772805: A Study to Evaluate the Effect of Food on Nemtabrutinib (MK-1026) in Healthy Participants (MK-1026-016)
Official title: A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 1 (FMF1) in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
Secondary outcomes:
measure: Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Maximum Observed Concentration (Cmax) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib
timeFrame: Predose and at designated timepoints (up to approximately 2 weeks postdose)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 30 days
measure: Number of Participants Who Discontinue the Study Intervention Due to an AE
timeFrame: Up to approximately 14 days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Labcorp Clinical Research Unit Inc. (Site 0001)
state: Hawaii
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: