Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males

This study has been completed.

First Received: May 24, 2007 No Changes Posted

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00479297

Purpose

To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary:

To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.

Condition	Intervention	Phase
Alzheimer Disease	Drug: SAM-531	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Male Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety and tolerability

Secondary Outcome Measures:

Pharmacokinetics and pharmacodynamics

Estimated Enrollment:	72
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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 17.6 to 26.4 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 (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479297

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3193A1-101
Study First Received:	May 24, 2007
Last Updated:	May 24, 2007
ClinicalTrials.gov Identifier:	NCT00479297 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Healthy

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009