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

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

SAM-315

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria:

Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = [weight (kg)]/[height (m)]2).
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria

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, digital 12-lead ECGs, or clinical laboratory test results.
Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.

Sites / Locations

Outcomes

Primary Outcome Measures

Safety and tolerability

Secondary Outcome Measures

Pharmacokinetics and pharmacodynamics

Full Information

NCT ID

NCT00480467

First Posted

May 29, 2007

Last Updated

December 3, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00480467

Brief Title

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

Official Title

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 Administered Orally to Healthy Japanese Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2007 (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 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.

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

Double

Allocation

Randomized

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

SAM-315

Primary Outcome Measure Information:

Title

Safety and tolerability

Secondary Outcome Measure Information:

Title

Pharmacokinetics and pharmacodynamics

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Men aged 20 to 45 years (inclusive) at the time of getting informed consent. Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = [weight (kg)]/[height (m)]2). Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility. Exclusion criteria 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, digital 12-lead ECGs, or clinical laboratory test results. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.

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

Ibaraki Pref

ZIP/Postal Code

305-0856

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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