Odiparcil QT Definitive Study

Atrial Fibrillation Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00437242
• Other study ID #: ITI103221
• Status: Terminated
• Phase: Phase 1
• First received: February 16, 2007
• Last updated: May 31, 2012
• Start date: October 2006

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion:

• Healthy volunteers

Exclusion:

• Cardiac abnormalities

• Hepatic or renal insufficiency

• Anti-coagulant medications

• Bleeding history

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Fibrillation, Atrial

Intervention

Drug:
• Odiparcil

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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