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

Phase 1

Terminated

• Conditions: Sleep; Healthy Volunteers
• Interventions: Drug: PF-04457845 / matched placebo

• Registration Number: NCT01002625
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Study Start: 2009-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. PF-04457845 followed by placebo	PF-04457845 / matched placebo	PF-04457845 followed by placebo
2. Placebo followed by PF-04457845	PF-04457845 / matched placebo	Placebo followed by PF-04457845

Primary Outcome Measures

Name	Time	Method
Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100).	3 days

Secondary Outcome Measures

Name	Time	Method
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
Percentage of total sleep time spent in Stage 1 sleep	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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States