A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

NCT01002625

Last updated date
Study Location
Pfizer Investigational Site
New York, New York, 10019, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sleep, Healthy Volunteers
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects between the ages of 18 and 55 years Body Mass Index (BMI) between 17.5 and 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of any active sleep disorder.


- History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy,
sleep apnea, phase advance or delay syndromes within the past 5 years.


- Currently on or planning to be involved in night or rotating shift work or traveling
across more than four time zones in 14 days prior to screening.

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Sleep, Healthy VolunteersA Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
NCT01002625
  1. New York, New York
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
Official Title  ICMJE Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects Of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
Brief Summary PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.
Detailed Description The trial was terminated prematurely December 3, 2009 owing to an operational error. There were no safety or efficacy concerns relating to the study and the decision to terminate the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Sleep
  • Healthy Volunteers
Intervention  ICMJE Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
Study Arms  ICMJE
  • Experimental: 1. PF-04457845 followed by placebo
    PF-04457845 followed by placebo
    Intervention: Drug: PF-04457845 / matched placebo
  • Experimental: 2. Placebo followed by PF-04457845
    Placebo followed by PF-04457845
    Intervention: Drug: PF-04457845 / matched placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 14, 2010)
18
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2009)
16
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years Body Mass Index (BMI) between 17.5 and 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

  • History of any active sleep disorder.
  • History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years.
  • Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01002625
Other Study ID Numbers  ICMJE B0541008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP