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

Cascadian Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: tucatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03758339

ONT-380-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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