NCT00316459

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
Last Updated

April 13, 2007

Status Verified

April 1, 2007

First QC Date

April 18, 2006

Last Update Submit

April 11, 2007

Conditions

HealthyLong QT Syndrome

Keywords

HealthyCardiacPharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.

Interventions

ERB-041DRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Long QT Syndrome

Interventions

ERB 041

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

May 1, 2006

Last Updated

April 13, 2007

Record last verified: 2007-04

Locations

US(1)