Covance Clinical Research Unit
Madison, Wisconsin, 53704, United States
Completed
NCT Number: NCT03758339
A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Tucatinib
DrugSingle dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
Primary outcomes
-
Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 14 days
PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
-
Apparent volume of distribution
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
-
Cumulative Aeu
Time frame: Up to 14 days
PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
-
Percentage excreted in urine (Feu)
Time frame: Up to 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
-
Cumulative Feu
Time frame: Up 14 days
PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
-
Renal clearance
Time frame: Up to 14 days
PK outcome endpoint of tucatinib derived from urine collections
-
Amount excreted in feces [Aef]
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
-
Cumulative Aef
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
-
Percentage excreted in feces [Fef]
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
-
Cumulative Fef
Time frame: Up to 14 days
PK outcome endpoint of total radioactivity derived from feces collection
Secondary outcomes
-
Relative abundance of tucatinib and its metabolites eliminated in urine and feces
Time frame: Up to 14 days
-
Relative abundance of tucatinib and its metabolites in plasma
Time frame: Up to 14 days
-
Incidence of adverse events (AEs)
Time frame: Up to 14 days
Sponsors and collaborators
Lead sponsor
Cascadian Therapeutics Inc.
Industry
Registry information
Official study title
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [¹⁴C]-Tucatinib Following a Single Oral Dose in Healthy Male and Female Subjects
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Nov 29, 2018
- Registry last updated
- Nov 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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