Status:
COMPLETED
A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
Lead Sponsor:
Cascadian Therapeutics Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03758339
Start Date
December 30 2017
End Date
January 30 2018
Last Update
November 29 2018
Active Locations (1)
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1
Covance Clinical Research Unit
Madison, Wisconsin, United States, 53704