Back to resultsOdiparcil QT Definitive Study
Primary Purpose
Fibrillation, Atrial, Atrial Fibrillation
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Odiparcil
Sponsored by
About this trial
This is an interventional treatment trial for Fibrillation, Atrial focused on measuring interval,, atrial fibrillation, QT,, odiparcil,
Eligibility Criteria
Inclusion:
- Healthy volunteers
Exclusion:
- Cardiac abnormalities
- Hepatic or renal insufficiency
- Anti-coagulant medications
- Bleeding history
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours
Secondary Outcome Measures
Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437242
Brief Title
Odiparcil QT Definitive Study
Official Title
A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrillation, Atrial, Atrial Fibrillation
Keywords
interval,, atrial fibrillation, QT,, odiparcil,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
54 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Odiparcil
Primary Outcome Measure Information:
Title
demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion:
Healthy volunteers
Exclusion:
Cardiac abnormalities
Hepatic or renal insufficiency
Anti-coagulant medications
Bleeding history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Odiparcil QT Definitive Study
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