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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00316459
First received: April 18, 2006
Last updated: April 11, 2007
Last verified: April 2007
  Purpose

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


Condition Intervention Phase
Healthy
Long QT Syndrome
Drug: ERB-041
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval

Secondary Outcome Measures:
  • To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.

Estimated Enrollment: 64
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316459

Locations
United States, Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316459     History of Changes
Other Study ID Numbers: 3142A2-110
Study First Received: April 18, 2006
Last Updated: April 11, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy
Cardiac
Pharmacokinetics

Additional relevant MeSH terms:
Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014