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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547560
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : April 4, 2011
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Healthy Drug: GSI-953 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly Subjects
Study Start Date : August 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 Name: Begacestat, WAY-210953, PF-05212362

Primary Outcome Measures :
  1. The pharmacokinetic and pharmacodynamic profile for the elderly subjects. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) [ Time Frame: 6 months ]
  2. Pharmacodynamics (PD) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00547560

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth Identifier: NCT00547560     History of Changes
Other Study ID Numbers: 3183A1-102
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: April 2011

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer Disease