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

April 11, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 19, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

April 13, 2007

Last Update Submitted That Met QC Criteria

April 11, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3142A2-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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