Breast Cancer Clinical Trial
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
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 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.
Full 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, study treatment will be dosed in 3 sequential treatment periods:
Treatment A: Oral doses of 300mg tucatinib for 5 days
Treatment B: Oral doses of matching placebo for tucatinib for 5 days
Treatment C: A single oral dose of 400 mg of moxifloxacin
Patients will be randomized based on 2-Williams-square design to 1 of 6 treatment sequences to maintain the study blind for tucatinib and placebo.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There is 1 Location for this study
Dallas Texas, 75247, United States
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