A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)

NCT06698016 | Completed Phase 1 FDA Drug

• 1 other identifier: 1026-014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy 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 efavirenz.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Predose and at designated time points (up to 2 weeks)

Secondary Outcomes (8)

• Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib

  Predose and at designated time points (up to 24 hours postdose)

• Maximum Plasma Concentration (Cmax) of Nemtabrutinib

  Predose and at designated time points (up to 2 weeks)

• Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib

  Predose and at designated time points (up to 2 weeks postdose)

• Apparent Clearance (CL/F) of Nembrutinib

  Predose and at designated time points (up to 2 weeks)

• Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib

  Predose and at designated time points (up to 2 weeks)

Study Arms (2)

Period 1: Nemtabrutinib

EXPERIMENTAL

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

Drug: Nemtabrutinib

Period 2: Nemtabrutinib + Efavirenz

EXPERIMENTAL

Participants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11.

Drug: Nemtabrutinib; Drug: Efavirenz

Interventions

Nemtabrutinib DRUG

Oral administration

Also known as: MK-1026, ARQ 531

Period 1: Nemtabrutinib; Period 2: Nemtabrutinib + Efavirenz

Efavirenz DRUG

Oral administration

Period 2: Nemtabrutinib + Efavirenz

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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) \> 18 kg/m2 and ≤ 32 kg/m\^2

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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Altasciences Clinical Kansas, Inc. (Site 0001)

Overland Park, Kansas, 66212, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ARQ531; efavirenz

Study Officials

• Medical Director

  Merck Sharpe & 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 18, 2024
• First Posted: November 20, 2024
• Study Start: July 25, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)