Clinical trial NCT01092845: Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Sleep
Keywords: Double-Blind
Randomized
Placebo-Controlled
2-Way Crossover
Polysomnographic Endpoints
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)
timeFrame: 3 days
Secondary outcomes:
measure: Minutes of REM sleep time
timeFrame: 3 days
measure: Percentage of total sleep time spent in Stage 1 sleep
timeFrame: 3 days
measure: Percentage of total sleep time spent in Stage 2 sleep
timeFrame: 3 days
measure: Percentage of total sleep time spent in Stage 3-4 sleep
timeFrame: 3 days
measure: Total sleep time
timeFrame: 3 days
measure: Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO)
timeFrame: 3 days
measure: Number of arousals after sleep onset (NASO)
timeFrame: 3 days
measure: Latency to persistent sleep
timeFrame: 3 days
measure: Plasma concentrations of PF-04457845
timeFrame: 3 days
measure: Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))
timeFrame: 3 days
measure: Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG
timeFrame: 3 days
measure: Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG
timeFrame: 3 days
measure: Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep
timeFrame: 3 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: