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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00547560
First received: October 18, 2007
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention Phase
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: An Ascending Multiple Dose Study Of The Safety, Pharmacokinetics, And Pharmacodynamics Of GSI-953 Administered Orally To Healthy Elderly 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:
  • The pharmacokinetic and pharmacodynamic profile for the elderly subjects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamics (PD) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547560

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00547560     History of Changes
Other Study ID Numbers: 3183A1-102, B1941003
Study First Received: October 18, 2007
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013