Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
- Registration Number
- NCT01092845
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo followed by PF-04457845 PF-04457845 / matched placebo - PF-04457845 followed by placebo PF-04457845 / matched placebo -
- Primary Outcome Measures
Name Time Method Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) 3 days
- Secondary Outcome Measures
Name Time Method Plasma concentrations of PF-04457845 3 days Total sleep time 3 days Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO) 3 days Latency to persistent sleep 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 3 days Minutes of REM sleep time 3 days Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA)) 3 days Percentage of total sleep time spent in Stage 1 sleep 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 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 3 days Percentage of total sleep time spent in Stage 2 sleep 3 days Percentage of total sleep time spent in Stage 3-4 sleep 3 days Number of arousals after sleep onset (NASO) 3 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New York, New York, United States