Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects
NCT00366483
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
-Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and women ≥ 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight ≥ 50 kg. -Healthy as determined by the investigator.
-History of any neuropsychiatric disorder. -History of drug or alcohol
abuse.
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Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects | ||||||
Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Lecozotan SR Administered Orally to Healthy Young and Elderly Subjects | ||||||
Brief Summary | To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | ||||||
Condition ICMJE | Alzheimer Disease | ||||||
Intervention ICMJE | Drug: Lecozotan SR | ||||||
Study Arms ICMJE | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Enrollment ICMJE | 40 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date ICMJE | Not Provided | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: -Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and women ? 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight ? 50 kg. -Healthy as determined by the investigator. Exclusion Criteria: -History of any neuropsychiatric disorder. -History of drug or alcohol abuse. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | France | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00366483 | ||||||
Other Study ID Numbers ICMJE | 3098B1-130 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | March 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |