Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

Phase 1

Terminated

• Conditions: Alzheimer Disease
• Interventions: Drug: SAM-315

• Registration Number: NCT00474552
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-17
• Study Start: 2007-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-13
• Last Update Posted: 2008-02-18

Recruitment & Eligibility

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

Inclusion Criteria

Young healthy subjects:

• Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1.
• Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.

Elderly Healthy subjects:

• Men or women aged 65 years and above as of study day 1.
• BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.

Exclusion Criteria

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• History of any clinically important drug allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SAM-315	Experimental-Placebo Comparator

Primary Outcome Measures

Name	Time	Method
safety, tolerability and PK	10 months