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

This study has been completed.
Sponsor:
Information provided by:
Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00772512
First received: October 13, 2008
Last updated: March 17, 2010
Last verified: April 2009
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 its metabolite, PF-04831035 [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Taisho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00772512     History of Changes
Other Study ID Numbers: B0911003
Study First Received: October 13, 2008
Last Updated: March 17, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014