Effects of Tucatinib on Cardiac Repolarization in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-03-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The study will be double-blind in regard to tucatinib and placebo study treatments and open-label for the positive control, moxifloxacin.

Intervention Type DRUG

400mg single oral dose

Interventions

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tucatinib

300mg oral dose

Intervention Type DRUG

placebo

Matching placebo for tucatinib

Intervention Type DRUG

moxifloxacin

400mg single oral dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes