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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772512
First Posted: October 15, 2008
Last Update Posted: March 19, 2010
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.
Information provided by:
Taisho Pharmaceutical Co., Ltd.
  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 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Taisho Pharmaceutical Co., Ltd.:

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

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

Enrollment: 13
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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:

  • Evidence or history of clinically significant medical illness
  • A history of seizures, including childhood febrile seizures
  • Any condition possibly affecting drug absorption
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00772512


Locations
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10019
Sponsors and Collaborators
Taisho Pharmaceutical Co., Ltd.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00772512     History of Changes
Other Study ID Numbers: B0911003
First Submitted: October 13, 2008
First Posted: October 15, 2008
Last Update Posted: March 19, 2010
Last Verified: April 2009

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