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Completed

NCT Number: NCT00772512

A Study Of The Effect Of PF-04802540 On Sleep Measures

The purpose of this study is to determine if PF-04802540 decreases REM sleep.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New York, 10019, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight >45 kg (99 lbs)
  • Non-users of nicotine

Exclusion criteria

  • Evidence or history of clinically significant medical illness
  • A history of seizures, including childhood febrile seizures
  • Any condition possibly affecting drug absorption

Treatment and study plan

PF-04802540

Drug

5 mg capsule, single dose

Placebo

Drug

Placebo capsule, single dose

Primary outcomes

  1. REM sleep percentage

    Time frame: 1 day

Secondary outcomes

  1. REM sleep latency

    Time frame: 1 day

  2. Beta EEG power

    Time frame: 1 day

  3. Plasma concentrations of PF-04802540 and its metabolite, PF-04831035

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effects Of PF-04802540 On Polysomnography Endpoints In Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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