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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 : July 15, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Sleep Drug: PF-04457845 / matched placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers
Study Start Date : April 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: PF-04457845 followed by placebo Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
Experimental: Placebo followed by PF-04457845 Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo


Outcome Measures

Primary Outcome Measures :
  1. Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Minutes of REM sleep time [ Time Frame: 3 days ]
  2. Percentage of total sleep time spent in Stage 1 sleep [ Time Frame: 3 days ]
  3. Percentage of total sleep time spent in Stage 2 sleep [ Time Frame: 3 days ]
  4. Percentage of total sleep time spent in Stage 3-4 sleep [ Time Frame: 3 days ]
  5. Total sleep time [ Time Frame: 3 days ]
  6. 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 ]
  7. Number of arousals after sleep onset (NASO) [ Time Frame: 3 days ]
  8. Latency to persistent sleep [ Time Frame: 3 days ]
  9. Plasma concentrations of PF-04457845 [ Time Frame: 3 days ]
  10. Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA)) [ Time Frame: 3 days ]
  11. 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 ]
  12. 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 ]
  13. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092845


Locations
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10019
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01092845     History of Changes
Other Study ID Numbers: B0541010
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: July 2010

Keywords provided by Pfizer:
Double-Blind
Randomized
Placebo-Controlled
2-Way Crossover
Polysomnographic Endpoints