Clinical trial NCT06698016: A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)
Official title: A Study to Evaluate the Effect of Multiple Oral Doses of Efavirenz on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria

The key inclusion criteria include but are not limited to the following:

* 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

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 (malignancy)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
timeFrame: Predose and at designated time points (up to 2 weeks)
Secondary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib
timeFrame: Predose and at designated time points (up to 24 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of Nemtabrutinib
timeFrame: Predose and at designated time points (up to 2 weeks)
measure: Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib
timeFrame: Predose and at designated time points (up to 2 weeks postdose)
measure: Apparent Clearance (CL/F) of Nembrutinib
timeFrame: Predose and at designated time points (up to 2 weeks)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib
timeFrame: Predose and at designated time points (up to 2 weeks)
measure: Apparent Terminal Half-life (t1/2) of Nemtabrutinib
timeFrame: Predose and at designated time points (up to 2 weeks)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 months
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 2 months
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc. (Site 0001)
state: Kansas
Study officials:
affiliation: Merck Sharpe & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: