A Study of the Effect of Diltiazem on the Plasma Levels of Nemtabrutinib (MK-1026-022)
- Registration Number
- NCT07232589
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Be in good health
- BMI between 18.5 and 32 kg/m2, inclusive
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period 1: Nemtabrutinib Nemtabrutinib Participants will receive nemtabrutinib followed by a protocol specified wash-out period. Period 2: Diltiazem + Nemtabrutinib Nemtabrutinib Participants will receive diltiazem plus nemtabrutinib. Period 2: Diltiazem + Nemtabrutinib Diltiazem Participants will receive diltiazem plus nemtabrutinib.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.