A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
- Registration Number
- NCT03758339
- Lead Sponsor
- Cascadian Therapeutics Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tucatinib tucatinib -
- Primary Outcome Measures
Name Time Method 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
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
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
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
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
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
Cumulative Fef Up to 14 days PK outcome endpoint of total radioactivity derived from feces collection
- Secondary Outcome Measures
Name Time Method 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 Incidence of adverse events (AEs) Up to 14 days
Trial Locations
- Locations (1)
Covance Clinical Research Unit
🇺🇸Madison, Wisconsin, United States