- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00441987
Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953
April 28, 2022 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shinagawa-ku
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Kitashinagawa, Shinagawa-ku, Japan, 141-0001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 120 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Dose of GSI-953
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants reporting Adverse Event
Time Frame: 10 months
|
Safety
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
February 28, 2007
First Submitted That Met QC Criteria
February 28, 2007
First Posted (Estimate)
March 1, 2007
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
April 28, 2022
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3183A1-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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