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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-013 | Other Identifier | MSD |
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The goal of this study is to learn what happens to levels of nemtabrutinib in a 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 itraconazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Nemtabrutinib | Experimental | Participants receive a single oral dose of nemtabrutinib followed by a protocol specified wash-out period. |
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| Period 2: Nemtabrutinib + Itraconazole | Experimental | Participants receive oral doses of itraconazole once daily on Days 1 to 13 with a single oral dose of nemtabrutinib given with itraconazole on Day 4. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemtabrutinib | Drug | Oral administration |
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| 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 in plasma. | At designated time points (up to approximately 10 days postdose) |
| 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 in plasma. | At designated time points (up to approximately 10 days postdose) |
| Maximum Plasma Concentration (Cmax) of Nemtabrutinib | Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma. | At designated time points (up to approximately 10 days postdose) |
| Time of Maximum Plasma Concentration (Tmax) of Nemtabrutinib | Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma. | At designated time points (up to approximately 10 days postdose) |
| Apparent Terminal Half-life (t1/2) of Nemtabrutinib | Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma. | At designated time points (up to approximately 10 days postdose) |
| Apparent Clearance (CL/F) of Nemtabrutinib | Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma. | At designated time points (up to approximately 10 days postdose) |
| Apparent Volume of Distribution (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 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 6 weeks |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
Assigned male sex at birth.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. (Site 0001) | Honolulu | Hawaii | 96813 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000721068 | ARQ531 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Oral administration |
|
Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma. |
| At designated time points (up to approximately 10 days postdose) |
| Number of Participants Who Discontinue from 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 experience an AE will be reported. |
| Up to approximately 6 weeks |
| D010879 |
| Piperazines |