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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: PF-04802540

• Registration Number: NCT00772512
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Study Start: 2008-11
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-04
• Last Update Submitted: 2010-03-17
• Last Update Posted: 2010-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	Placebo	-
A	PF-04802540	-
B	PF-04802540	-

Primary Outcome Measures

Name	Time	Method
REM sleep percentage	1 day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States