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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy
Sleep

Treatments

Drug: PF-04457845 / matched placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01092845
B0541010

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

30 participants in 2 patient groups

PF-04457845 followed by placebo
Experimental group
Treatment:
Drug: PF-04457845 / matched placebo
Drug: PF-04457845 / matched placebo
Placebo followed by PF-04457845
Experimental group
Treatment:
Drug: PF-04457845 / matched placebo
Drug: PF-04457845 / matched placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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