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Completed

NCT Number: NCT06698016

A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy 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 efavirenz.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Kansas, Inc. (Site 0001)

Overland Park, Kansas, 66212, 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) > 18 kg/m2 and ≤ 32 kg/m^2

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

Efavirenz

Drug

Oral administration

Primary outcomes

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

    Time frame: Predose and at designated time points (up to 2 weeks)

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

Secondary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib

    Time frame: Predose and at designated time points (up to 24 hours postdose)

    Blood samples will be collected to determine the AUC0-24hr of nemtabrutinib.

  2. Maximum Plasma Concentration (Cmax) of Nemtabrutinib

    Time frame: Predose and at designated time points (up to 2 weeks)

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

  3. Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib

    Time frame: Predose and at designated time points (up to 2 weeks postdose)

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

  4. Apparent Clearance (CL/F) of Nembrutinib

    Time frame: Predose and at designated time points (up to 2 weeks)

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

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

    Time frame: Predose and at designated time points (up to 2 weeks)

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

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

    Time frame: Predose and at designated time points (up to 2 weeks)

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

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

    Time frame: Up to approximately 2 months

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

  8. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 2 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to 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 Effect of Multiple Oral Doses of Efavirenz on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2024
Registry last updated
Nov 20, 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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