Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Phase 1
Completed
- Conditions
- Long QT SyndromeHealthy
- 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
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.