Odiparcil QT Definitive Study

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00437242
• Collaborator: (none)
• Enrollment: 54
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fibrillation, Atrial; Atrial Fibrillation	Drug: Odiparcil	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• 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.
• Study Start Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion:

• Healthy volunteers

Exclusion:

• Cardiac abnormalities

• Hepatic or renal insufficiency

• Anti-coagulant medications

• Bleeding history

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00437242
• Other Study ID Numbers: ITI103221
• First Posted: Feb 19, 2007
• Last Update Posted: Jun 4, 2012
• Last Verified: Mar 1, 2011

• Keywords provided by GlaxoSmithKline: interval,; atrial fibrillation; QT,; odiparcil,
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jun 4, 2012