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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-016 | Other Identifier | MSD |
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The goal of the study is to learn what happens to levels of nemtabrutinib in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given under fasted (on an empty stomach) and fed (after a high-fat meal) conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemtabrutinib Treatment A | Experimental | Participants receive a single dose of nemtabrutinib on Day 1 under fasted conditions (on an empty stomach after a 10-hour overnight fast) |
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| Nemtabrutinib Treatment B | Experimental | Participants receive a single dose of nemtabrutinib on Day 1 under fed conditions (after a high-fat meal) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemtabrutinib | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib | Blood samples will be collected to determine the AUC0-inf of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Taken for the Drug to Appear in the Systemic Circulation Following Administration (Tlag) of Nemtabrutinib | Blood samples will be collected to determine the Tlag of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Terminal Elimination Half-Life (t1/2) of Nemtabrutinib |
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Inclusion Criteria:
Inclusion criteria include, but are not limited to:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
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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 |
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Blood samples will be collected to determine the t1/2 of nemtabrutinib in plasma. |
| Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib | Blood samples will be collected to determine the CL/F of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Nemtabrutinib | Blood samples will be collected to determine the Vz/F of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Nemtabrutinib | Blood samples will be collected to determine the AUC0-last of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Maximum Observed Concentration (Cmax) of Nemtabrutinib | Blood samples will be collected to determine the Cmax of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib | Blood samples will be collected to determine the Tmax of nemtabrutinib in plasma. | Predose and at designated timepoints (up to approximately 2 weeks postdose) |
| 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 the study intervention, whether or not considered related to the study intervention. | Up to approximately 30 days |
| Number of Participants Who Discontinue the Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. | Up to approximately 14 days |