NCT03777761

Effects of Tucatinib on Cardiac Repolarization in Healthy Participants

A Phase 1, Randomized, Partially Double-Blind, Placebo- and Positive-controlled Study to Evaluate the Effect of Tucatinib on Cardiac Repolarization in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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, 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

• Healthy

Interventions

Type	Name	Description
DRUG	tucatinib	300mg oral dose
DRUG	placebo	Matching placebo for tucatinib
DRUG	moxifloxacin	400mg single oral dose

Timeline

• Start date: 2018-12-06
• Primary completion: 2019-03-11
• Completion: 2019-03-11
• First posted: 2018-12-17
• Last updated: 2019-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study