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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

SAM-531

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion criteria

Men aged 20 to 45 years, inclusive, at screening.
Elderly men or women aged 65 years and above as of screening.
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.

Exclusion critereia

Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening.
Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm Description

SAM 531 + placebo

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Pharmacokinetics and pharmacodynamics

Full Information

NCT ID

NCT00479349

First Posted

May 24, 2007

Last Updated

July 6, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00479349

Brief Title

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

Official Title

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Young Male and Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

SAM 531 + placebo

Intervention Type

Drug

Intervention Name(s)

SAM-531

Intervention Description

Multiple ascending doses of SAM 531: 1,5; 3 and 5 mg.

Primary Outcome Measure Information:

Title

Safety and tolerability

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Pharmacokinetics and pharmacodynamics

Time Frame

9 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Men aged 20 to 45 years, inclusive, at screening. Elderly men or women aged 65 years and above as of screening. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg. Exclusion critereia Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be below the upper limit of normal at screening. Tobacco use or consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or carbonated beverages) or alcoholic beverages within 48 hours before study day 1 until the end of the inpatient confinement period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Facility Information:

City

Tokyo

ZIP/Postal Code

170-0003

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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