Healthy
Conditions
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.
Interventions
DRUGNemtabrutinib
Oral administration
DRUGEfavirenz
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
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) \> 18 kg/m2 and ≤ 32 kg/m\^2
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib | Predose and at designated time points (up to 2 weeks) | Blood samples will be collected to determine the AUC0-inf of nemtabrutinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Nemtabrutinib | Predose and at designated time points (up to 2 weeks) | Blood samples will be collected to determine the Cmax of nemtabrutinib. |
| Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib | Predose and at designated time points (up to 2 weeks postdose) | Blood samples will be collected to determine the Tmax of nemtabrutinib. |
| Apparent Clearance (CL/F) of Nembrutinib | Predose and at designated time points (up to 2 weeks) | Blood samples will be collected to determine the CL/F of nemtabrutinib. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib | Predose and at designated time points (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hr of nemtabrutinib. |
| Apparent Terminal Half-life (t1/2) of Nemtabrutinib | Predose and at designated time points (up to 2 weeks) | Blood samples will be collected to determine the t1/2 of nemtabrutinib. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 2 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 2 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib | Predose and at designated time points (up to 2 weeks) | Blood samples will be collected to determine the Vz/F of nemtabrutinib. |
Countries
United States
Outcome results
None listed