To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.
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.
abuse.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | |||||||
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
