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CompletedNCT06586671Updated Sep 19, 2024

A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)

A Phase 1 interventional study of Nemtabrutinib in Hematological Malignancy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Nov 2023, 2 years 10 months ago, and no results have been posted to the registry.
  • Registered 1 year after the study started (first participant enrolled Aug 2023, registered Sep 2024).
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.

02

Conditions studied

  • Hematological Malignancy
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

  • Is in good health before randomization
  • Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion criteria

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 with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Nemtabrutinib Form A

    Participants receive nemtabrutinib form A orally.

    Drug: Nemtabrutinib

  • Experimental
    Nemtabrutinib Form B

    Participants receive nemtabrutinib form B orally.

    Drug: Nemtabrutinib

  • Experimental
    Nemtabrutinib Form C

    Participants receive nemtabrutinib form C orally.

    Drug: Nemtabrutinib

Interventions

  • DrugNemtabrutinib

    Oral administration

    Also known as: MK-1026, ARQ-531

06

What researchers measure

Primary outcomes

  1. Parts 1 and 2: 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.

    Time frame: At designated time points (up to approximately 2 weeks)

  2. Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Nemtabrutinib

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

    Time frame: At designated time points (up to approximately 2 weeks)

Secondary outcomes

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

    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.

    Time frame: Up to approximately 2 months

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

    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 discontinue study due to an AE will be reported.

    Time frame: Up to approximately 2 months

07

Study locations

1 site
  • QPS-MRA, LLC-Early Phase (Site 0002)
    South Miami, Florida 33143, United States
08

References and documents

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586671
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Aug 28, 2023
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023
Last update
Sep 19, 2024

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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