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NCT00499642 Clinical Trial

Study Evaluating the Effect of Lecozotan SR on the QTc Interval

Healthy Clinical Trial

Official title:
A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00499642
Other study ID # 3098B1-133
Secondary ID
Status Completed
Phase Phase 1
First received July 10, 2007
Last updated December 19, 2007
Start date June 2007
Est. completion date August 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Women and men aged 18 to 55 years inclusive.

- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

- History of any clinically important drug allergy.

- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lecozotan SR

• Moxifloxacin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the effect of drug administration on QTc interval.
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