Study Evaluating the Effect of Lecozotan SR on the QTc Interval

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: July 10, 2007
Last updated: December 19, 2007
Last verified: December 2007

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

Condition Intervention Phase
Alzheimer Disease
Drug: Lecozotan SR
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess the effect of drug administration on QTc interval.

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

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

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 identifier: NCT00499642

Rennes, France, 35000
Rueil-Malmaison, France, 92502
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France:
  More Information

No publications provided Identifier: NCT00499642     History of Changes
Other Study ID Numbers: 3098B1-133
Study First Received: July 10, 2007
Last Updated: December 19, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy Subjects

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on April 21, 2014