Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Seagen Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Body mass index between 18 and 32 kg/m\^2 and a total body weight between 50 and 100 kg
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiograms, vital signs measurements, or clinical laboratory evaluations
Female subjects participating in the study will be of non-childbearing potential. Male subjects will be surgically sterile for at least 90 days or will agree to use contraception during the study and for 90 days after last dose of study drug.
Japanese subjects:
1. Must have been born in Japan
2. Must have 2 biological Japanese parents and 4 biological Japanese grandparents as confirmed by interview
3. Must have spent less than 10 years outside of Japan, and has no significant changes in lifestyle, including diet, since leaving Japan
You may not be if
Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
Current condition possibly affecting drug absorption
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
History of alcoholism or drug/chemical abuse within 2 years of check-in
History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
Positive hepatitis panel and/or positive human immunodeficiency (HIV) test
Liver function tests, serum creatinine, hemoglobin, or hematocrit values outside of the normal reference range
Single 12-lead ECG demonstrating QTcF\>450 msec for males or \>470 msec for females
Participation in a clinical study involving administration of an investigational drug in the past 30 days from last dose or 5 half-lives (whichever is longer)
Use of any products known to alter drug absorption, metabolism or elimination processes, including St. John's wort and known strong inhibitors or inducers of CYP3A4 or CYP2C8, within 30 days
Use of or intention to use any prescription or nonprescription products, including vitamins, minerals and herbal preparations within 14 days
Use of tobacco- or nicotine-containing products within 3 months
Receipt of blood products within 2 months
Donation of blood from 56 days before the Screening Visit, plasma from 2 weeks before the Screening Visit or platelets from 6 weeks before the Screening Visit
Poor peripheral venous access
Have previously completed or withdrawn from this study or any other study investigating tucatinib and have previously received the study drug
