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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nemtabrutinib; Drug: Efavirenz

• Registration Number: NCT06698016
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-25
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Last Update Submitted: 2024-11-18
• Study First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Period 2: Nemtabrutinib + Efavirenz	Nemtabrutinib	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.
Period 1: Nemtabrutinib	Nemtabrutinib	Participants receive a single dose of nemtabrutinib followed by a protocol specified wash-out period.
Period 2: Nemtabrutinib + Efavirenz	Efavirenz	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib	Predose and at designated time points (up to 2 weeks)	Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.

Secondary Outcome Measures

Name	Time	Method
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)	Blood samples will be collected to determine the AUC0-24hr of nemtabrutinib.
Maximum Plasma Concentration (Cmax) of Nemtabrutinib	Predose and at designated time points (up to 2 weeks)	Blood samples will be collected to determine the Cmax of nemtabrutinib.
Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib	Predose and at designated time points (up to 2 weeks postdose)	Blood samples will be collected to determine the Tmax of nemtabrutinib.
Apparent Clearance (CL/F) of Nembrutinib	Predose and at designated time points (up to 2 weeks)	Blood samples will be collected to determine the CL/F of nemtabrutinib.
Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib	Predose and at designated time points (up to 2 weeks)	Blood samples will be collected to determine the Vz/F of nemtabrutinib.
Apparent Terminal Half-life (t1/2) of Nemtabrutinib	Predose and at designated time points (up to 2 weeks)	Blood samples will be collected to determine the t1/2 of nemtabrutinib.
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 2 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 2 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Trial Locations

Locations (1)

Altasciences Clinical Kansas, Inc. (Site 0001); 🇺🇸 Overland Park, Kansas, United States