A Study Of The Effect Of PF-04802540 On Sleep Measures
March 17, 2010 updated by: Taisho Pharmaceutical Co., Ltd.
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
The purpose of this study is to determine if PF-04802540 decreases REM sleep.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10019
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: C
|
Placebo capsule, single dose
|
|
Experimental: A
|
5 mg capsule, single dose
15 mg capsule, single dose
|
|
Experimental: B
|
5 mg capsule, single dose
15 mg capsule, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
REM sleep percentage
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
REM sleep latency
Time Frame: 1 day
|
1 day
|
|
Beta EEG power
Time Frame: 1 day
|
1 day
|
|
Plasma concentrations of PF-04802540 and its metabolite, PF-04831035
Time Frame: 2 days
|
2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 13, 2008
First Submitted That Met QC Criteria
October 13, 2008
First Posted (Estimate)
October 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 19, 2010
Last Update Submitted That Met QC Criteria
March 17, 2010
Last Verified
April 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- B0911003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.