Know Cancer

or
forgot password

A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects


Phase 1
18 Years
50 Years
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects


Inclusion Criteria:



- Men or women of nonchildbearing potential,

- 18-50 years old.

- Healthy as determined by the investigator, including physical examination, laboratory
test results, and medical history.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

QTc interval

Outcome Time Frame:

3 days

Safety Issue:

Yes

Principal Investigator

Puma

Investigator Role:

Study Director

Investigator Affiliation:

Biotechnology

Authority:

United States: Food and Drug Administration

Study ID:

3144A1-105

NCT ID:

NCT00708903

Start Date:

May 2008

Completion Date:

July 2008

Related Keywords:

  • Breast Cancer
  • Thorough QTc study
  • Breast Neoplasms

Name

Location

Seattle, Washington  98195