A Phase 1 Study to Investigate the Effects of Talampanel on the Heart Rhythm
NCT00964730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135
Last updated 2010-04-07
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
- 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
-
administered three times a day over 9 days and a single dose administered on Day 10
Sponsors & Collaborators
-
Cetero Research, San Antonio
collaborator NETWORK -
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Principal Investigators
-
Craig R Sprenger, MD · Cetero Research - Fargo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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