NCT06688045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

November 14, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

November 12, 2024

Last Update Submit

November 12, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

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

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

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

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

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

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

  • Maximum Plasma Concentration (Cmax) of Nemtabrutinib

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

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

  • Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib

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

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

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

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

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

  • Apparent Clearance (CL/F) of Nemtabrutinib

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

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

  • Apparent Volume of Distribution (Vz/F) of Nemtabrutinib

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

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

Secondary Outcomes (2)

  • Number of Participants Who Experience an Adverse Event (AE)

    Up to approximately 6 weeks

  • Number of Participants Who Discontinue from Study Due to an AE

    Up to approximately 6 weeks

Study Arms (2)

Period 1: Nemtabrutinib

EXPERIMENTAL

Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period.

Drug: Nemtabrutinib

Period 2: Nemtabrutinib + Itraconazole

EXPERIMENTAL

Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4.

Drug: NemtabrutinibDrug: Itraconazole

Interventions

NemtabrutinibDRUG

Oral administration

Also known as: MK-1026, ARQ-531
Period 1: NemtabrutinibPeriod 2: Nemtabrutinib + Itraconazole
ItraconazoleDRUG

Oral administration

Period 2: Nemtabrutinib + Itraconazole

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAssigned male sex at birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Honolulu, Hawaii, 96813, United States

Location

Related Links

MeSH Terms

Interventions

ARQ531Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

October 30, 2023

Primary Completion

January 6, 2024

Study Completion

January 6, 2024

Last Updated

November 14, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(1)