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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sleep Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1. PF-04457845 followed by placebo

PF-04457845 followed by placebo

Group Type EXPERIMENTAL

PF-04457845 / matched placebo

Intervention Type DRUG

PF-04457845 4 mg tablet once daily / matched placebo

2. Placebo followed by PF-04457845

Placebo followed by PF-04457845

Group Type EXPERIMENTAL

PF-04457845 / matched placebo

Intervention Type DRUG

PF-04457845 4 mg tablet once daily / matched placebo

Interventions

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PF-04457845 / matched placebo

PF-04457845 4 mg tablet once daily / matched placebo

Intervention Type DRUG

PF-04457845 / matched placebo

PF-04457845 4 mg tablet once daily / matched placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes