Study Evaluating the Effect of Lecozotan SR on the QTc Interval - Full Text View

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

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

Moxifloxacin Moxifloxacin hydrochloride Lecozotan

U.S. FDA Resources

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

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

Study ID Numbers:	3098B1-133
First Received:	July 10, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00499642
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

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Moxifloxacin

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Healthy

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Nervous System Diseases

Tauopathies

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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