Odiparcil QT Definitive Study

This study has been terminated.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 16, 2007
Last updated: May 31, 2012
Last verified: March 2011

This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.

Condition Intervention Phase
Fibrillation, Atrial
Atrial Fibrillation
Drug: Odiparcil
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 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.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

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

Estimated Enrollment: 54
Study Start Date: October 2006
Intervention Details:
    Drug: Odiparcil
    Other Name: Odiparcil

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes


  • Healthy volunteers


  • Cardiac abnormalities
  • Hepatic or renal insufficiency
  • Anti-coagulant medications
  • Bleeding history
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437242

United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437242     History of Changes
Other Study ID Numbers: ITI103221
Study First Received: February 16, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014