Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males

Phase 1

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT00480467
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-31
• Study Completion: 2007-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

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

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and pharmacodynamics