A Study To Establish The Effects Of PF-04457845 On Sleep... | NCT01002625

Studies
A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

NCT01002625

Sponsor

Pfizer

Status

Terminated

Last Update Posted

Jul 8, 2010Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Sleep
Healthy Volunteers

Interventions

PF-04457845 / matched placebo
PF-04457845 / matched 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

Jul 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

See termination reason in detailed description.

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 26, 2009

First Submission Date that Met QC Criteria

Oct 26, 2009

First Posted Date

Oct 27, 2009Estimated

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

Jul 6, 2010

Last Update Posted Date

Jul 8, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.

Detailed Description

The trial was terminated prematurely December 3, 2009 owing to an operational error. There were no safety or efficacy concerns relating to the study and the decision to terminate the trial.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. PF-04457845 followed by placebo	Experimental	PF-04457845 followed by placebo	Drug: PF-04457845 / matched placebo
2. Placebo followed by PF-04457845	Experimental	Placebo followed by PF-04457845	Drug: PF-04457845 / matched placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04457845 / matched placebo	Drug	PF-04457845 4 mg tablet once daily / matched placebo	1. PF-04457845 followed by placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100).		3 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of total sleep time spent in Stage 1 sleep		3 days
Percentage of total sleep time spent in Stage 2 sleep		3 days
Percentage of total sleep time spent in Stage 3-4 sleep

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male subjects between the ages of 18 and 55 years Body Mass Index (BMI) between 17.5 and 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

History of any active sleep disorder.
History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years.
Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening.

Accepts Healthy Volunteers

Yes

Sex

Male

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 York	New York	10019	United States

References Module

Citations

Not provided