A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03758339

Run by

Cascadian Therapeutics Inc.

People needed

8

Starts

2017-12-30

Expected to finish

2018-01-30

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Research Unit — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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