Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: SRA-444

• Registration Number: NCT00499200
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Start: 2007-10
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-07
• Last Update Posted: 2008-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SRA-444 + Placebo	SRA-444	Experimental; Placebo

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease	after each dose group completion
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET	1 month