Clinical trial NCT01002625: A 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: TERMINATED
Phase: PHASE1
Conditions: Sleep
Healthy Volunteers
Keywords: Double-Blind Randomized Placebo-Controlled 2-Way Crossover Polysomnographic Endpoints
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 18
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.

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.

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; 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.

Primary outcomes:
measure: Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100).
timeFrame: 3 days
Secondary outcomes:
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: Sleep efficiency (total sleep time/time in bed * 100).
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.
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
measure: For definitions of polysomnography variable objectives and endpoints see Appendix 3
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: