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

Phase 1

Completed

• Conditions: Long QT Syndrome; Healthy

• Registration Number: NCT00316459
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-19
• Study First Posted: 2006-04-20
• Study Start: 2006-05
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-11
• Last Update Posted: 2007-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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