Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: SAM-531

• Registration Number: NCT00479349
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy Japanese young male and elderly subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-28
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-06
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SAM-531	SAM 531 + placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	9 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and pharmacodynamics	9 months