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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nemtabrutinib

• Registration Number: NCT06772818
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-02
• Primary Completion: 2023-12-20
• Study Completion: 2024-02-16
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nemtabrutinib Treatment A	Nemtabrutinib	Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast)
Nemtabrutinib Treatment B	Nemtabrutinib	Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal)

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.

Secondary Outcome Measures

Name	Time	Method
Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.
Number of Participants Who Discontinue the Study Intervention Due to an AE	Up to 14 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Maximum Observed Concentration (Cmax) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib	Predose and at designated timepoints (up to approximately 2 weeks postdose)	Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Number of Participants Who Experience an Adverse Event (AE)	Up to 30 days	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Trial Locations

Locations (1)

Labcorp Clinical Research Unit Inc. (Site 0001); 🇺🇸 Honolulu, Hawaii, United States