Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00316459

Purpose

To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.

Condition	Intervention	Phase
Healthy Long QT Syndrome	Drug: ERB-041	Phase I

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomized, Double-Blind, Placebo and Moxifloxacin (Open-Label) Controlled, 4-Period, Crossover Study of the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval

Secondary Outcome Measures:

To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.

Estimated Enrollment:	64
Study Start Date:	May 2006

Eligibility

Criteria

Inclusion Criteria:

Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG.
Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.

Exclusion Criteria:

A family history of long QT syndrome and/or cardiac death.
Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316459

Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3142A2-110
Study First Received:	April 18, 2006
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00316459
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy
Cardiac
Pharmacokinetics

Study placed in the following topic categories:

Heart Diseases
Cardiovascular Abnormalities
Moxifloxacin
Long QT Syndrome

Healthy
Congenital Abnormalities
Heart Defects, Congenital
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009