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A Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT01002625•Pfizer

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

Pfizer Investigational Site

New York, New York, United States

Key Dates

Start Date

November 1, 2009

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

July 8, 2010

Enrollment

ACTUAL participants

Conditions

SleepHealthy Volunteers

Interventions

PF-04457845 / matched placebo

DRUG

PF-04457845 / matched placebo

DRUG

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

NCT01778504

Neuropsychiatric DisorderNeurological Disorder+2 more

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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