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Effects of Tucatinib on Cardiac Repolarization in Healthy Participants

NCT03777761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2019-04-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

tucatinib

300mg oral dose

DRUG

placebo

Matching placebo for tucatinib

DRUG

moxifloxacin

400mg single oral dose

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Woolery, PharmD, BCOP · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2019-03-11
Completion
2019-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777761 on ClinicalTrials.gov