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

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.

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Key information

Conditions

Healthy Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kitashinagawa, Shinagawa-ku, 141-0001, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSI-953

Drug

Primary outcomes

Number of participants reporting Adverse Event

Time frame: 10 months

Safety

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Mar 1, 2007
Registry last updated: May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed