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
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 April 17, 2014