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This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.
This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tucatinib | Drug | Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf]) | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| AUC from time 0 to last quantifiable concentration | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| Maximum observed concentration | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| Time of maximum observed concentration | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| Apparent terminal elimination half-life | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| Apparent total clearance | PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles | Up to 14 days |
| Apparent volume of distribution | PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles |
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of tucatinib and its metabolites eliminated in urine and feces | Up to 14 days | |
| Relative abundance of tucatinib and its metabolites in plasma | Up to 14 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alex Vo, PhD | Cascadian Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000705452 | tucatinib |
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| Up to 14 days |
| AUC[0-inf] plasma tucatinib/total radioactivity ratio | AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity | Up to 14 days |
| AUC[0-inf] blood/plasma ratio | AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity | Up to 14 days |
| Amount excreted in urine (Aeu) | PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections | Up to 14 days |
| Cumulative Aeu | PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections | Up to 14 days |
| Percentage excreted in urine (Feu) | PK outcome endpoint of tucatinib and total radioactivity derived from urine collections | Up to 14 days |
| Cumulative Feu | PK outcome endpoint of tucatinib and total radioactivity derived from urine collections | Up 14 days |
| Renal clearance | PK outcome endpoint of tucatinib derived from urine collections | Up to 14 days |
| Amount excreted in feces [Aef] | PK outcome endpoint of total radioactivity derived from feces collection | Up to 14 days |
| Cumulative Aef | PK outcome endpoint of total radioactivity derived from feces collection | Up to 14 days |
| Percentage excreted in feces [Fef] | PK outcome endpoint of total radioactivity derived from feces collection | Up to 14 days |
| Cumulative Fef | PK outcome endpoint of total radioactivity derived from feces collection | Up to 14 days |
| Incidence of adverse events (AEs) |
| Up to 14 days |