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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00547560
Pfizer
Completed
Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population

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Similar Trials

Study Evaluating Multiple Doses Of GSI-953 Within The Elderly Population
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
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
GSI+Placebo
Intervention: Drug: GSI-953
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
October 2009
October 2009   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00547560
3183A1-102
B1941003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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