NCT00494962

Brief Summary

To determine the bioequivalence between two 5-mg tablets of lecozotan and the new 10-mg tablet of lecozotan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 alzheimer-disease

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

June 29, 2007

Last Update Submit

December 3, 2007

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic (PK) analyses

Interventions

lecozotan SRDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Generally healthy, man and women, aged 18 to 50 years.

You may not qualify if:

  • History or active presence of clinically important medical disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

lecozotan

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Germany, medinfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2007

First Posted

July 2, 2007

Study Start

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

DE(1)