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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-022 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Nemtabrutinib | Experimental | Participants will receive nemtabrutinib followed by a protocol specified wash-out period. |
|
| Period 2: Diltiazem + Nemtabrutinib | Experimental | Participants will receive diltiazem plus nemtabrutinib. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemtabrutinib | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib | Blood samples will be collected to determine the AUC0-inf of nemtabrutinib. | Up to approximately 4 weeks |
| Maximum Plasma Concentration (Cmax) of Nemtabrutinib | Blood samples will be collected to determine the Cmax of nemtabrutinib. | Up to approximately 4 weeks |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Nemtabrutinib | Blood samples will be collected to determine the AUC0-last of nemtabrutinib. | Up to approximately 4 weeks |
| Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib | Blood samples will be collected to determine the Tmax of nemtabrutinib. | Up to approximately 4 weeks |
| Apparent Terminal Half-life (t1/2) of Nemtabrutinib | Blood samples will be collected to determine the t1/2 of nemtabrutinib. | Up to approximately 4 weeks |
| Apparent Clearance (CL/F) of Nemtabrutinib | Blood samples will be collected to determine the CL/F of nemtabrutinib. | Up to approximately 4 weeks |
| Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib | Blood samples will be collected to determine the Vz/F of nemtabrutinib. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison ( Site 0001) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000721068 | ARQ531 |
| D004110 | Diltiazem |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Diltiazem | Drug | Oral administration |
|
| Up to approximately 4 weeks |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 3 weeks |