A Study Of The Effect Of PF-04802540 On Sleep Measures - Full Text View

Sponsors and Collaborators:	Pfizer Taisho Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00772512

Purpose

The purpose of this study is to determine if PF-04802540 decreases REM sleep.

Condition	Intervention	Phase
Healthy	Drug: PF-04802540 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effects Of PF-04802540 On Polysomnography Endpoints In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

Secondary Outcome Measures:

REM sleep latency [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Beta EEG power [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Plasma concentrations of PF-04802540 and PF-04831035 [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: PF-04802540 5 mg capsule, single dose
B: Experimental	Drug: PF-04802540 15 mg capsule, single dose
C: Placebo Comparator	Drug: Placebo Placebo capsule, single dose

Eligibility

Criteria

Inclusion Criteria:

Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive
Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight >45 kg (99 lbs)
Non-users of nicotine

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772512

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, New York
Pfizer Investigational Site	Recruiting
New York, New York, United States, 10019

Sponsors and Collaborators

Pfizer

Taisho Pharmaceuticals

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0911003
Study First Received:	October 13, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00772512
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PF-04802540, polysomnography, REM, cross over

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009