Status:
COMPLETED
Study Evaluating the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Long QT Syndrome
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00316459
Start Date
May 1 2006
Last Update
April 13 2007
Active Locations (1)
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1
Miami, Florida, United States, 33126