NCT00547560

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 4, 2011

Status Verified

April 1, 2011

Enrollment Period

2.2 years

First QC Date

October 18, 2007

Last Update Submit

April 1, 2011

Conditions

Healthy

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • The pharmacokinetic and pharmacodynamic profile for the elderly subjects.

    6 months

Secondary Outcomes (2)

  • Pharmacokinetics (PK)

    6 months

  • Pharmacodynamics (PD)

    6 months

Study Arms (1)

GSI+Placebo

OTHER
Drug: GSI-953

Interventions

GSI-953DRUG

Oral capsule, 10- and 50-mg, either once a day for 14 days or twice a day for 14 days, depending on cohort assignment.

Also known as: Begacestat, WAY-210953, PF-05212362
GSI+Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Miami, Florida, 33126, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

begacestat

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 22, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 4, 2011

Record last verified: 2011-04

Locations

US(1)