Clinical trial NCT06688045: A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)
Official title: A Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single-dose Pharmacokinetics of Nemtabrutinib in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 15
Sex: MALE
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 this study is to learn what happens to levels of nemtabrutinib in a 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 itraconazole.


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) of18 to 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 (malignancy).

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Maximum Plasma Concentration (Cmax) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Apparent Terminal Half-life (t1/2) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Apparent Clearance (CL/F) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
measure: Apparent Volume of Distribution (Vz/F) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 10 days postdose)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 6 weeks
measure: Number of Participants Who Discontinue from Study Due to an AE
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Labcorp Clinical Research Unit Inc. (Site 0001)
state: Hawaii
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: