Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

This study has been completed.

First Received on June 27, 2008. Last Updated on January 29, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00708903

Purpose

The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).

Condition	Intervention	Phase
Breast Cancer	Drug: HKI-272 Other: Placebo Drug: Moxifloxacin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride HKI-272

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

QTc interval [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 HKI-272	Drug: HKI-272
Placebo Comparator: 2 Placebo	Other: Placebo
Active Comparator: 3 Moxifloxacin	Drug: Moxifloxacin

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708903

Locations

United States, Washington

Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00708903 History of Changes
Other Study ID Numbers:	3144A1-105
Study First Received:	June 27, 2008
Last Updated:	January 29, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Thorough QTc study

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012