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Trial record 2 of 4 for:    GSI-953
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Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00441987
First received: February 28, 2007
Last updated: June 17, 2010
Last verified: June 2010
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 96
Study Start Date: February 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (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
5-4-12, Kitashinagawa, Shinagawa-ku, Japan, 141-0001
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00441987     History of Changes
Other Study ID Numbers: 3183A1-101
Study First Received: February 28, 2007
Last Updated: June 17, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Japanese
Healthy
Alzheimers Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013