Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGtucatinib
Single dose of 300 mg of \[¹⁴C\]-tucatinib containing approximately 150 μCi of \[¹⁴C\] radioactivity
Sponsors
Cascadian Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, or lab evaluations * Body mass index (BMI) between 18 and 32 kg/m² * Weight between 50 and 100 kg * Females must be of non-childbearing potential * Males must agree to use contraception
Exclusion criteria
* History of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder * Any condition affecting drug absorption * History of hypersensitivity or allergy to any drug compound, food, or other substance * History of alcoholism or drug/chemical abuse within 2 years * Use of prescription products within 28 days prior to check in * Use of tobacco- or nicotine-containing products within 3 months prior to check in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Fef | Up to 14 days | PK outcome endpoint of total radioactivity derived from feces collection |
| Amount excreted in feces [Aef] | Up to 14 days | PK outcome endpoint of total radioactivity derived from feces collection |
| Cumulative Aef | Up to 14 days | PK outcome endpoint of total radioactivity derived from feces collection |
| Percentage excreted in feces [Fef] | Up to 14 days | PK outcome endpoint of total radioactivity derived from feces collection |
| Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf]) | Up to 14 days | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles |
| AUC from time 0 to last quantifiable concentration | Up to 14 days | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles |
| Maximum observed concentration | Up to 14 days | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles |
| Time of maximum observed concentration | Up to 14 days | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles |
| Apparent terminal elimination half-life | Up to 14 days | PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles |
| Apparent total clearance | Up to 14 days | PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles |
| Apparent volume of distribution | Up to 14 days | PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles |
| AUC[0-inf] plasma tucatinib/total radioactivity ratio | Up to 14 days | AUC\[0-inf\] of plasma tucatinib relative to AUC\[0-inf\] of plasma total radioactivity |
| AUC[0-inf] blood/plasma ratio | Up to 14 days | AUC\[0-inf\] of whole blood total radioactivity to AUC\[0-inf\] of plasma total radioactivity |
| Amount excreted in urine (Aeu) | Up to 14 days | PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections |
| Cumulative Aeu | Up to 14 days | PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections |
| Percentage excreted in urine (Feu) | Up to 14 days | PK outcome endpoint of tucatinib and total radioactivity derived from urine collections |
| Cumulative Feu | Up 14 days | PK outcome endpoint of tucatinib and total radioactivity derived from urine collections |
| Renal clearance | Up to 14 days | PK outcome endpoint of tucatinib derived from urine collections |
Secondary
| Measure | Time frame |
|---|---|
| Relative abundance of tucatinib and its metabolites in plasma | Up to 14 days |
| Incidence of adverse events (AEs) | Up to 14 days |
| Relative abundance of tucatinib and its metabolites eliminated in urine and feces | Up to 14 days |
Countries
United States
Outcome results
None listed