NCT00964730

A Phase 1 Study to Investigate the Effects of Talampanel on the Heart Rhythm

A Phase I, Single-Center, Double-Blind, Randomized, Placebo- and Positive- Controlled, Parallel Group, Thorough QT/QTc Study to Evaluate the Effect of Talampanel on Cardiac Repolarization in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess whether multiple doses of Talampanel increase the QT interval when compared to placebo

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Talampanel	titrated to 50mg three times a day over 9 days and a single dose administered on Day 10
DRUG	Moxifloxacin	Placebo administered three times a day over 9 days and a single dose of moxifloxacin administered on Day 10
DRUG	Placebo	administered three times a day over 9 days and a single dose administered on Day 10

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2009-08-25
• Last updated: 2010-04-07

Locations

1 site across 1 country: United States