Healthy
Conditions
Brief summary
The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.
Interventions
DRUGNemtabrutinib
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include, but are not limited to: * Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization * Has a body mass index (BMI) 18.0 to 32.0 kg/m\^2 (inclusive)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma. |
| Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma. |
| Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma. |
| Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma. |
| Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma. |
| Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to 30 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Number of Participants Who Discontinue the Study Intervention Due to an AE | Up to 14 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Maximum Observed Concentration (Cmax) of Nemtabrutinib | Predose and at designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma. |
Countries
United States
Outcome results
None listed