A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
NCT01002625
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | ||||
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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 |
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Intervention ICMJE | Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo | |||
Study Arms ICMJE |
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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 | 18 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |