A Study Of The Effect Of PF-04802540 On Sleep Measures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00772512
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : March 19, 2010
Information provided by:
Taisho Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04802540 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: A Drug: PF-04802540
5 mg capsule, single dose
Experimental: B Drug: PF-04802540
15 mg capsule, single dose
Placebo Comparator: C Drug: Placebo
Placebo capsule, single dose

Primary Outcome Measures :
  1. REM sleep percentage [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. REM sleep latency [ Time Frame: 1 day ]
  2. Beta EEG power [ Time Frame: 1 day ]
  3. Plasma concentrations of PF-04802540 and its metabolite, PF-04831035 [ Time Frame: 2 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  • Evidence or history of clinically significant medical illness
  • A history of seizures, including childhood febrile seizures
  • Any condition possibly affecting drug absorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00772512

United States, New York
Pfizer Investigational Site
New York, New York, United States, 10019
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Taisho Pharmaceutical Co., Ltd. Identifier: NCT00772512     History of Changes
Other Study ID Numbers: B0911003
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: March 19, 2010
Last Verified: April 2009

Keywords provided by Taisho Pharmaceutical Co., Ltd.:
PF-04802540, polysomnography, REM, cross over