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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy; Long QT Syndrome

Treatments: Drug: ERB-041

Study type: Interventional

Funder types: Industry

Identifiers

NCT00316459

3142A2-110

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind