Study Evaluating the Effect of Lecozotan SR on the QTc Interval

This study has been completed.

First Received: July 10, 2007 Last Updated: December 19, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00499642

Purpose

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

Condition	Intervention	Phase
Alzheimer Disease Healthy	Drug: Lecozotan SR Drug: Moxifloxacin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Lecozotan

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To assess the effect of drug administration on QTc interval.

Study Start Date:	June 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499642

Locations

France

Rennes, France, 35000

Rueil-Malmaison, France, 92502

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For France: infomedfrance@wyeth.com

More Information

No publications provided

Study ID Numbers:	3098B1-133
Study First Received:	July 10, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00499642 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; United States: Food and Drug Administration

Keywords provided by Wyeth:

Healthy Subjects

Additional relevant MeSH terms:

Anti-Infective Agents
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Moxifloxacin
Therapeutic Uses
Dementia
Tauopathies

ClinicalTrials.gov processed this record on February 08, 2010