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Completed

NCT Number: NCT06772818

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit Inc. (Site 0001)

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nemtabrutinib

Drug

Oral Tablet

Other names: MK-1026, ARQ-531

Primary outcomes

  1. Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib

    Time frame: 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 outcomes

  1. Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib

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

    Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma.

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

    Time frame: 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.

  3. Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib

    Time frame: 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.

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

    Time frame: 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.

  5. Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib

    Time frame: 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.

  6. Maximum Observed Concentration (Cmax) of Nemtabrutinib

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

    Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.

  7. Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib

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

    Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.

  8. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  9. Number of Participants Who Discontinue the Study Intervention Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Effect of Food on the Pharmacokinetics of the Nemtabrutinib Final Market Formulation 2 (FMF2) in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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