NCT01002625

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

July 8, 2010

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

October 26, 2009

Last Update Submit

July 6, 2010

Conditions

SleepHealthy Volunteers

Keywords

Double-Blind Randomized Placebo-Controlled 2-Way Crossover Polysomnographic Endpoints

Outcome Measures

Primary Outcomes (1)

  • Percentage of total sleep time spent in REM (ie, time spent in REM/total sleep time * 100).

    3 days

Secondary Outcomes (14)

  • Percentage of total sleep time spent in Stage 1 sleep

    3 days

  • Percentage of total sleep time spent in Stage 2 sleep

    3 days

  • Percentage of total sleep time spent in Stage 3-4 sleep

    3 days

  • Total sleep time

    3 days

  • Sleep efficiency (total sleep time/time in bed * 100).

    3 days

  • +9 more secondary outcomes

Study Arms (2)

1. PF-04457845 followed by placebo

EXPERIMENTAL

PF-04457845 followed by placebo

Drug: PF-04457845 / matched placebo

2. Placebo followed by PF-04457845

EXPERIMENTAL

Placebo followed by PF-04457845

Drug: PF-04457845 / matched placebo

Interventions

PF-04457845 / matched placeboDRUG

PF-04457845 4 mg tablet once daily / matched placebo

1. PF-04457845 followed by placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects between the ages of 18 and 55 years Body Mass Index (BMI) between 17.5 and 30.5 kg/m2; and a total body weight \>50 kg

You may not qualify if:

  • 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.

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

MeSH Terms

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

July 8, 2010

Record last verified: 2010-07

Locations

US(1)