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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01092845
First received: March 23, 2010
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Healthy
Sleep
Drug: PF-04457845 / matched placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minutes of REM sleep time [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Percentage of total sleep time spent in Stage 1 sleep [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Percentage of total sleep time spent in Stage 2 sleep [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Percentage of total sleep time spent in Stage 3-4 sleep [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Total sleep time [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Number of arousals after sleep onset (NASO) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Latency to persistent sleep [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Plasma concentrations of PF-04457845 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA)) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately before lights off for each PSG [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Beta-band spectral power (qEEG) measured with eyes open and eyes closed while subjects are awake immediately after lights on for each PSG [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Beta-band spectral power (qEEG) measured while subjects are asleep during the sleep onset period (SOP) and first 3 periods of NREM sleep [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04457845 followed by placebo Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
Experimental: Placebo followed by PF-04457845 Drug: PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092845

Locations
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10019
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01092845     History of Changes
Other Study ID Numbers: B0541010
Study First Received: March 23, 2010
Last Updated: July 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Double-Blind
Randomized
Placebo-Controlled
2-Way Crossover
Polysomnographic Endpoints

ClinicalTrials.gov processed this record on August 19, 2014