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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316459
• Other study ID #: 3142A2-110
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2006
• Last updated: April 11, 2007
• Start date: May 2006

Study information

• Verified date: April 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Long QT Syndrome

Intervention

Drug:
• ERB-041

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval
Secondary	To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.