Odiparcil QT Definitive Study

Phase 1

Terminated

• Conditions: Fibrillation, Atrial; Atrial Fibrillation

• Registration Number: NCT00437242
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Status Verified: 2011-03
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States