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

Healthy Volunteers 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: Terminated

Administrative data

• NCT number: NCT01002625
• Other study ID #: B0541008
• Status: Terminated
• Phase: Phase 1
• First received: October 26, 2009
• Last updated: July 6, 2010
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: January 2010
• Est. primary completion date: January 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; 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

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

Related Conditions & MeSH terms

• Healthy Volunteers
• 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 * 100).		3 days	No
Secondary	Percentage of total sleep time spent in Stage 1 sleep		3 days	No
Secondary	Percentage of total sleep time spent in Stage 2 sleep		3 days	No
Secondary	Percentage of total sleep time spent in Stage 3-4 sleep		3 days	No
Secondary	Total sleep time		3 days	No
Secondary	Sleep efficiency (total sleep time/time in bed * 100).		3 days	No
Secondary	Wake after sleep onset (sum of wake time during sleep and prior to final awakening) and wake time after sleep) (WASO).		3 days	No
Secondary	Number of arousals after sleep onset (NASO		3 days	No
Secondary	Latency to persistent sleep		3 days	No
Secondary	Plasma concentrations of PF-04457845.		3 days	No
Secondary	Plasma concentrations of fatty acid amides.		3 days	No
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	No
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	No
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	No
Secondary	For definitions of polysomnography variable objectives and endpoints see Appendix 3		3 days	No

External Links

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