Study Evaluating the Effect of Lecozotan SR on the QTc Interval
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease; Healthy
Intervention: Lecozotan SR (Drug); Moxifloxacin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For France: infomedfrance@wyeth.com
Summary
This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled,
4-period crossover study.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Primary outcome: To assess the effect of drug administration on QTc interval.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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).
Locations and Contacts
Rennes 35000, France
Rueil-Malmaison 92502, France
Additional Information
Starting date: June 2007
Ending date: August 2007
Last updated: December 19, 2007
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