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

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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep; Healthy Volunteers
• Intervention / Treatment: Drug: PF-04457845 / matched placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1. PF-04457845 followed by placebo; PF-04457845 followed by placebo	Drug: PF-04457845 / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo
EXPERIMENTAL: 2. Placebo followed by PF-04457845; Placebo followed by PF-04457845	Drug: PF-04457845 / matched placebo; PF-04457845 4 mg tablet once daily / matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (ACTUAL): January 1, 2010
• Study Completion (ACTUAL): January 1, 2010

Study Registration Dates

• First Submitted: October 26, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (ESTIMATE): October 27, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2010
• Last Update Submitted That Met QC Criteria: July 6, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Double-Blind Randomized Placebo-Controlled 2-Way Crossover Polysomnographic Endpoints
• Other Study ID Numbers: B0541008