Evaluation Of Striatal Glucose Metabolism With Positron E... | NCT01103726

Studies
Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects

NCT01103726

Sponsor

Pfizer

Status

Completed

Last Update Posted

Nov 16, 2011Estimated

Enrollment

34Actual

Phase

Phase 1

Conditions

Healthy

Interventions

PF-02545920
placebo
PF-02545920
PF-02545920
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

Apr 14, 2010

First Posted Date

Apr 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 11, 2011

Last Update Posted Date

Nov 16, 2011Estimated

Name	Class
Yale University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage 1	Experimental		Drug: PF-02545920 Drug: placebo
Stage 2	Experimental		Drug: PF-02545920 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-02545920	Drug	1 and 5 mg tablets, 6 mg single dose	Stage 1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.		Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

Secondary Outcomes

Measure	Description	Time Frame
Whole brain glucose metabolic rate.		Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum.		Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
An informed consent document signed and dated by the subject
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

Women of reproductive potential
History of agranulocytosis or movement disorder
Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		New Haven	Connecticut	06511	United States
Pfizer Investigational Site

References Module

Citations

Not provided