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

NCT06586671 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1026-007MK-1026-007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (2)

• 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.

  At designated time points (up to approximately 2 weeks)

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

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

  At designated time points (up to approximately 2 weeks)

Secondary Outcomes (2)

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

  Up to approximately 2 months

• Number of Participants Who Discontinue Study Due to an AE

  Up to approximately 2 months

Study Arms (3)

Nemtabrutinib Form A

EXPERIMENTAL

Participants receive nemtabrutinib form A orally.

Drug: Nemtabrutinib

Nemtabrutinib Form B

EXPERIMENTAL

Participants receive nemtabrutinib form B orally.

Drug: Nemtabrutinib

Nemtabrutinib Form C

EXPERIMENTAL

Participants receive nemtabrutinib form C orally.

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

Oral administration

Also known as: MK-1026, ARQ-531

Nemtabrutinib Form A; Nemtabrutinib Form B; Nemtabrutinib Form C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤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 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

QPS-MRA, LLC-Early Phase (Site 0002)

South Miami, Florida, 33143, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

ARQ531

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 28, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)