Status:
COMPLETED
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
Lead Sponsor:
Seagen Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3...
Detailed Description
This study will evaluate the effects of a steady state therapeutic dose of tucatinib on QTcF (QT interval corrected for heart rate using Fridericia's method) in healthy individuals. In this design, st...
Eligibility Criteria
Inclusion
- Good health, determined by medical history, physical examination, 12-lead ECG, vital signs measurements, or clinical laboratory evaluations
- Body mass index (BMI) between 18 and 32 kg/m\^2
- Body weight between 50 and 100 kg
- Female subjects must be of non-childbearing potential
- Male subjects must agree to use contraception or be surgically sterile for at least 90 days
Exclusion
- Significant 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
- Single 12-lead ECG demonstrating QTcF \>450 msec for males or \>470 msec for females, or history/evidence of long QT syndrome
- History of alcoholism or drug/chemical abuse within 2 years
- Use of prescription products within 30 days prior to check in
- Use of nonprescription products within 14 days prior to check in, including vitamins, minerals, and herbal supplements
- Use of tobacco- or nicotine-containing products within 3 months prior to check in
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03777761
Start Date
December 6 2018
End Date
March 11 2019
Last Update
April 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Covance Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247