Healthy, Sleep
Conditions
Keywords
Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover, Polysomnographic Endpoints
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.
Interventions
PF-04457845 4 mg tablet once daily / matched placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of total sleep time spent in Stage 1 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 |
| 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 |
| Number of arousals after sleep onset (NASO) | 3 days |
| Minutes of REM sleep time | 3 days |
| Plasma concentrations of PF-04457845 | 3 days |
| Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA)) | 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 |
| 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 |
| Latency to persistent sleep | 3 days |
Countries
United States
Outcome results
None listed