Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults

Phase 1

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT00479440
• 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 adult subjects. To obtain a preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study Completion: 2007-03
• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-28
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-03
• Last Update Posted: 2007-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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