A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013)
- Registration Number
- NCT06688045
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
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)
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period 1: Nemtabrutinib Nemtabrutinib Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period. Period 2: Nemtabrutinib + Itraconazole Nemtabrutinib Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4. Period 2: Nemtabrutinib + Itraconazole Itraconazole Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma.
Maximum Plasma Concentration (Cmax) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma.
Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma.
Apparent Terminal Half-life (t1/2) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma.
Apparent Clearance (CL/F) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma.
Apparent Volume of Distribution (Vz/F) of Nemtabrutinib At designated time points (up to approximately 10 days postdose) Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 6 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue from Study Due to an AE Up to approximately 6 weeks An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit Inc. (Site 0001)
🇺🇸Honolulu, Hawaii, United States