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

NCT06772805 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1026-016MK-1026-016
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib

  Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.

  Predose and at designated timepoints (up to approximately 2 weeks postdose)

Secondary Outcomes (9)

• 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)

• Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib

  Predose and at designated timepoints (up to approximately 2 weeks postdose)

• Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib

  Predose and at designated timepoints (up to approximately 2 weeks postdose)

• Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib

  Predose and at designated timepoints (up to approximately 2 weeks postdose)

• 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)

Study Arms (2)

Nemtabrutinib Treatment A

EXPERIMENTAL

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

Drug: Nemtabrutinib

Nemtabrutinib Treatment B

EXPERIMENTAL

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

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

Oral Tablet

Also known as: MK-1026, ARQ-531

Nemtabrutinib Treatment A; Nemtabrutinib Treatment B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Honolulu, Hawaii, 96813, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ARQ531

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: July 24, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)