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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-012 | Other Identifier | MSD |
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The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin | Experimental | Participants receive a single oral dose of digoxin (Treatment A). |
|
| Digoxin + Nemtabrutinib | Experimental | Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin | Blood samples will be collected to determine the AUC0-Inf of digoxin. | At designated timepoints (up to approximately 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin | Blood samples will be collected to determine the AUC0-Last of digoxin. | At designated timepoints (up to approximately 7 days) |
| Maximum Plasma Concentration (Cmax) of Digoxin |
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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 |
|---|---|---|---|---|---|---|
| ICON (Site 0001) | Lenexa | Kansas | 66219 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| C000721068 | ARQ531 |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Nemtabrutinib |
| Drug |
Oral administration |
|
|
Blood samples will be collected to determine the Cmax of digoxin. |
| At designated timepoints (up to approximately 7 days) |
| Plasma Concentration 24 Hours Postdose (C24) of Digoxin | Blood samples will be collected to determine the C24 of digoxin. | At designated timepoints (up to approximately 24 hours) |
| Time to Maximum Plasma Concentration (Tmax) of Digoxin | Blood samples will be collected to determine the Tmax of digoxin. | Predose and at designated timepoints (up to approximately 7 days) |
| Apparent Terminal Half-life (t1/2) of Digoxin | Blood samples will be collected to determine t1/2 of digoxin. | At designated timepoints (up to approximately 7 days) |
| Apparent Clearance (CL/F) of Digoxin | Blood samples will be collected to determine the CL/F of digoxin. | At designated timepoints (up to approximately 7 days) |
| Apparent Volume of Distribution (Vz/F) of Digoxin | Blood samples will be collected to determine the Vz/F of digoxin. | At designated timepoints (up to approximately 7 days) |
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. | Up to approximately 8 weeks |
| Number of Participants Who Discontinue Study Due to an AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported. | Up to approximately 8 weeks |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |