Healthy Volunteers, 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.
Detailed description
The trial was terminated prematurely December 3, 2009 owing to an operational error. There were no safety or efficacy concerns relating to the study and the decision to terminate the trial.
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; and a 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 * 100). | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Sleep efficiency (total sleep time/time in bed * 100). | 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 |
| Percentage of total sleep time spent in Stage 1 sleep | 3 days |
| Plasma concentrations of PF-04457845. | 3 days |
| Plasma concentrations of fatty acid amides. | 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 |
| For definitions of polysomnography variable objectives and endpoints see Appendix 3 | 3 days |
| Latency to persistent sleep | 3 days |
Countries
United States
Outcome results
None listed