Back to resultsStudy Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Primary Purpose
Healthy, Long QT Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ERB-041
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy, Cardiac, Pharmacokinetics
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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00316459
First Posted
April 18, 2006
Last Updated
April 11, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00316459
Brief Title
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Long QT Syndrome
Keywords
Healthy, Cardiac, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ERB-041
Primary Outcome Measure Information:
Title
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval
Secondary Outcome Measure Information:
Title
To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
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