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Completed

NCT Number: NCT01092845

Study To Establish The Effects Of PF-04457845 On Sleep 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.

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Key information

Conditions

Healthy Sleep

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New York, 10019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04457845 / matched placebo

Drug

PF-04457845 4 mg tablet once daily / matched placebo

Primary outcomes

  1. Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)

    Time frame: 3 days

Secondary outcomes

  1. Minutes of REM sleep time

    Time frame: 3 days

  2. Percentage of total sleep time spent in Stage 1 sleep

    Time frame: 3 days

  3. Percentage of total sleep time spent in Stage 2 sleep

    Time frame: 3 days

  4. Percentage of total sleep time spent in Stage 3-4 sleep

    Time frame: 3 days

  5. Total sleep time

    Time frame: 3 days

  6. 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

  7. Number of arousals after sleep onset (NASO)

    Time frame: 3 days

  8. Latency to persistent sleep

    Time frame: 3 days

  9. Plasma concentrations of PF-04457845

    Time frame: 3 days

  10. Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))

    Time frame: 3 days

  11. 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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2010
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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