NCT00772512

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 19, 2010

Status Verified

April 1, 2009

Enrollment Period

3 months

First QC Date

October 13, 2008

Last Update Submit

March 17, 2010

Conditions

Healthy

Keywords

PF-04802540, polysomnography, REM, cross over

Outcome Measures

Primary Outcomes (1)

  • REM sleep percentage

    1 day

Secondary Outcomes (3)

  • REM sleep latency

    1 day

  • Beta EEG power

    1 day

  • Plasma concentrations of PF-04802540 and its metabolite, PF-04831035

    2 days

Study Arms (3)

A

EXPERIMENTAL
Drug: PF-04802540

B

EXPERIMENTAL
Drug: PF-04802540

C

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04802540DRUG

5 mg capsule, single dose

A
PlaceboDRUG

Placebo capsule, single dose

C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New York, New York, 10019, United States

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2008

First Posted

October 15, 2008

Study Start

November 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 19, 2010

Record last verified: 2009-04

Locations

US(1)