NCT01092845

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

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_1 healthy

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

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

March 23, 2010

Last Update Submit

November 30, 2018

Conditions

HealthySleep

Keywords

Double-BlindRandomizedPlacebo-Controlled2-Way CrossoverPolysomnographic Endpoints

Outcome Measures

Primary Outcomes (1)

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

    3 days

Secondary Outcomes (13)

  • Minutes of REM sleep time

    3 days

  • 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

  • +8 more secondary outcomes

Study Arms (2)

PF-04457845 followed by placebo

EXPERIMENTAL
Drug: PF-04457845 / matched placebo

Placebo followed by PF-04457845

EXPERIMENTAL
Drug: PF-04457845 / matched placebo

Interventions

PF-04457845 / matched placeboDRUG

PF-04457845 4 mg tablet once daily / matched placebo

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
  • 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

March 23, 2010

First Posted

March 25, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations

US(1)