Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population

April 1, 2011 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects

To assess the safety and tolerability of ascending, multiple, oral doses of GSI-953 in healthy elderly subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

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

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Pfizer Investigational Site

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women, greater than or equal to 65 years of age.
  • Women of nonchildbearing potential (WONCP) may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with FSH greater than or equal to 38 mIU/mL) and must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight >50 kg.

Exclusion Criteria:

n/a

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
Other: GSI+Placebo
Drug: GSI-953
Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.
Other Names:
  • Begacestat, WAY-210953, PF-05212362

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The pharmacokinetic and pharmacodynamic profile for the elderly subjects.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK)
Time Frame: 6 months
6 months
Pharmacodynamics (PD)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

August 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3183A1-102
  • B1941003

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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