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 diltiazem.
Interventions
DRUGNemtabrutinib
Oral administration
DRUGDiltiazem
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 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Be in good health * BMI between 18.5 and 32 kg/m2, inclusive
Exclusion criteria
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological (history of a bleeding disorder, abnormal bleeding or a hereditary or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intercranial hemorrhage, and chronic seizures) abnormalities or diseases * History of cancer (malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the AUC0-inf of nemtabrutinib. |
| Maximum Plasma Concentration (Cmax) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the Cmax of nemtabrutinib. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the AUC0-last of nemtabrutinib. |
| Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the Tmax of nemtabrutinib. |
| Apparent Terminal Half-life (t1/2) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the t1/2 of nemtabrutinib. |
| Apparent Clearance (CL/F) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the CL/F of nemtabrutinib. |
| Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib | Up to approximately 4 weeks | Blood samples will be collected to determine the Vz/F of nemtabrutinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 5 weeks | 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 3 weeks | 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. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed