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OpenTrials
Completed

NCT Number: NCT06688045

A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)

The goal of this study is to learn what happens to levels of nemtabrutinib in a person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called itraconazole.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

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

The key inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history, physical examination, vital sign (VS) measurements, electrocardiograms (ECGs) and laboratory safety tests performed before allocation.
  • Has a body mass index (BMI) of18 to 32 kg/m^2 (inclusive)

Exclusion criteria

The key exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), 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 administration

Other names: MK-1026, ARQ-531

Itraconazole

Drug

Oral administration

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

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

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

    Time frame: At designated time points (up to approximately 10 days postdose)

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

  3. Maximum Plasma Concentration (Cmax) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

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

  4. Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

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

  5. Apparent Terminal Half-life (t1/2) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

    Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.

  6. Apparent Clearance (CL/F) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

    Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.

  7. Apparent Volume of Distribution (Vz/F) of Nemtabrutinib

    Time frame: At designated time points (up to approximately 10 days postdose)

    Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.

Secondary outcomes

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

    Time frame: Up to approximately 6 weeks

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

  2. Number of Participants Who Discontinue from Study Due to an AE

    Time frame: Up to approximately 6 weeks

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single-dose Pharmacokinetics of Nemtabrutinib in Healthy Male Participants

Important dates

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

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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