Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953 - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00441987

Purpose

The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.

Condition	Intervention	Phase
Alzheimer Disease Healthy	Drug: GSI-953	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 (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study
Official Title:	A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 Administered Orally to Healthy Japanese Male Subjects and Healthy Elderly Male Japanese Subjects.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Healthy males aged 20 - 40 and healthy males aged greater than 65.
Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg.
Non-smokers or smoker of fewer than 10 cigarettes a day.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441987

Locations

Japan, Shinagawa-ku

5-4-12, Kitashinagawa, Shinagawa-ku, Japan, 141-0001

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3183A1-101
Study First Received:	February 28, 2007
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00441987
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

Japanese
Healthy
Alzheimers Disease

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:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009