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

Phase 1

Completed

• Conditions: Hematological Malignancy
• Interventions: Drug: Nemtabrutinib

• Registration Number: NCT06586671
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-28
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Submitted: 2024-09-06
• Last Update Posted: 2024-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nemtabrutinib Form A	Nemtabrutinib	Participants receive nemtabrutinib form A orally.
Nemtabrutinib Form B	Nemtabrutinib	Participants receive nemtabrutinib form B orally.
Nemtabrutinib Form C	Nemtabrutinib	Participants receive nemtabrutinib form C orally.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

QPS-MRA, LLC-Early Phase (Site 0002); 🇺🇸 South Miami, Florida, United States