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

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NCT01002625

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New York, New York, 10019 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01002625
Pfizer
Terminated
A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

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A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects Of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Sleep
  • Healthy Volunteers
Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01002625
B0541008
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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