A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-Blind, Randomized, Multiple-Dose, Placebo-Controlled, 2-Way Crossover Study To Study Effects Of PF-04457845 On Polysomnographic Endpoints In Healthy Volunteers

Conditions
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Sleep, Healthy Volunteers

Intervention / Treatment
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* Drug: PF-04457845 / matched placebo
* Drug: PF-04457845 / matched placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. PF-04457845 followed by placebo<br>PF-04457845 followed by placebo | Drug: PF-04457845 / matched placebo<br>* PF-04457845 4 mg tablet once daily / matched placebo<br>|
| Experimental: 2. Placebo followed by PF-04457845<br>Placebo followed by PF-04457845 | Drug: PF-04457845 / matched placebo<br>* PF-04457845 4 mg tablet once daily / matched placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100). |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| 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 | 
| Latency to persistent 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-Blind Randomized Placebo-Controlled 2-Way Crossover Polysomnographic Endpoints