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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00772512

Enrollment

Registered

2008-10-15

Start date

2008-11-30

Completion date

2009-02-28

Last updated

2010-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PF-04802540, polysomnography, REM, cross over

Brief summary

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

Interventions

DRUGPF-04802540

5 mg capsule, single dose

DRUGPlacebo

Placebo capsule, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
REM sleep percentage	1 day

Secondary

Measure	Time frame
REM sleep latency	1 day
Beta EEG power	1 day
Plasma concentrations of PF-04802540 and its metabolite, PF-04831035	2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026