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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092845
• Other study ID #: B0541010
• Status: Completed
• Phase: Phase 1
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sleep

Intervention

Drug:
• PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo
• PF-04457845 / matched placebo
PF-04457845 4 mg tablet once daily / matched placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time)		3 days
Secondary	Minutes of REM sleep time		3 days
Secondary	Percentage of total sleep time spent in Stage 1 sleep		3 days
Secondary	Percentage of total sleep time spent in Stage 2 sleep		3 days
Secondary	Percentage of total sleep time spent in Stage 3-4 sleep		3 days
Secondary	Total sleep time		3 days
Secondary	Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO)		3 days
Secondary	Number of arousals after sleep onset (NASO)		3 days
Secondary	Latency to persistent sleep		3 days
Secondary	Plasma concentrations of PF-04457845		3 days
Secondary	Plasma concentrations of fatty acid amides (N-arachidonyl ethanolamine (anandamide, AEA), palmitoylethanolamide (PEA), oleoylethanolamide (OEA) and linoleoyl ethanolamine (LEA))		3 days
Secondary	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
Secondary	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
Secondary	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

External Links

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