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Trial record 1 of 1 for:    NCT01092845
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Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01092845
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : December 4, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE March 25, 2010
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE April 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) [ Time Frame: 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01092845 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2010)
  • Minutes of REM sleep time [ Time Frame: 3 days ]
  • Percentage of total sleep time spent in Stage 1 sleep [ Time Frame: 3 days ]
  • Percentage of total sleep time spent in Stage 2 sleep [ Time Frame: 3 days ]
  • Percentage of total sleep time spent in Stage 3-4 sleep [ Time Frame: 3 days ]
  • Total sleep time [ Time Frame: 3 days ]
  • Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO) [ Time Frame: 3 days ]
  • Number of arousals after sleep onset (NASO) [ Time Frame: 3 days ]
  • Latency to persistent sleep [ Time Frame: 3 days ]
  • Plasma concentrations of PF-04457845 [ Time Frame: 3 days ]
  • Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA)) [ Time Frame: 3 days ]
  • Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG [ Time Frame: 3 days ]
  • Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG [ Time Frame: 3 days ]
  • Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep [ Time Frame: 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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 Not Provided
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
  • Healthy
  • Sleep
Intervention  ICMJE Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
Study Arms  ICMJE
  • Experimental: PF-04457845 followed by placebo
    Intervention: Drug: PF-04457845 / matched placebo
  • Experimental: 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2010)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2010)
20
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 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
  • 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 NCT01092845
Other Study ID Numbers  ICMJE B0541010
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 Center Pfizer
PRS Account Pfizer
Verification Date November 2018

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