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

An Open-Label, Two-Part, Two-Period Crossover Study to Determine Bioequivalence Between Nemtabrutinib FFP and FMF2 Formulations & FMF1 and FMF2 Formulations at 65 mg Single Dose in Healthy Male Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06586671

Enrollment

Registered

2024-09-19

Start date

2023-08-28

Completion date

2023-11-13

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancy

Brief 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.

Interventions

DRUGNemtabrutinib

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

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

The key

Design outcomes

Primary

Measure	Time frame	Description
Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib	At designated time points (up to approximately 2 weeks)	Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Nemtabrutinib	At designated time points (up to approximately 2 weeks)	Blood samples will be collected to determine the Cmax of nemtabrutinib.

Secondary

Measure	Time frame	Description
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 2 months	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.
Number of Participants Who Discontinue Study Due to an AE	Up to approximately 2 months	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026