Healthy
Conditions
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.
Interventions
DRUGNemtabrutinib
Oral administration
DRUGItraconazole
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed