Status:
TERMINATED
A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Sleep
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 als...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01002625
Start Date
November 1 2009
End Date
January 1 2010
Last Update
July 8 2010
Active Locations (1)
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1
Pfizer Investigational Site
New York, New York, United States, 10019