NCT01244880

Brief Summary

To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

3 active sites

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

November 5, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

November 5, 2010

Last Update Submit

March 19, 2014

Conditions

Healthy

Keywords

PF-02545920ketaminefMRIassociative Learning

Outcome Measures

Primary Outcomes (1)

  • Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks

    Day 1 of each treatment period

Secondary Outcomes (5)

  • Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging

    Day 1 of each treatment period

  • Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation

    Day 1 of each treatment period

  • N-back working memory task number correct

    Day 1 of each treatment period

  • Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score

    Day 1 of each treatment period

  • Clinician administered dissociative states scale (CADSS) total score

    Day 1 of each treatment period

Study Arms (4)

Saline/PF-02545920

EXPERIMENTAL

Treatments are co-administered

Other: SalineDrug: PF-02545920

Ketamine/PF-02545920

EXPERIMENTAL

Treatments are co-administered

Other: KetamineDrug: PF-02545920

Saline/Placebo

PLACEBO COMPARATOR

Treatments are co-administered

Other: SalineOther: Placebo

Ketamine/Placebo

EXPERIMENTAL

Treatments are co-administered

Other: KetamineOther: Placebo

Interventions

SalineOTHER

Saline infusion for 56 minutes

Saline/PF-02545920
PF-02545920DRUG

PF-02545920 10 mg single dose

Saline/PF-02545920
KetamineOTHER

Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes PF-02545920 10 mg tablet

Ketamine/PF-02545920
PlaceboOTHER

Placebo tablet single dose

Saline/Placebo

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Right handed as determined by handedness questionnaire.
  • Able to read and write English as a primary language.

You may not qualify if:

  • Female subjects who are pregnant or breastfeeding.
  • Any evidence of significant psychosis-like symptoms.
  • Known sensitivity to ketamine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

New Haven, Connecticut, 06510, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06519, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520, United States

Location

Related Links

MeSH Terms

Interventions

Sodium Chloride2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinolineKetamine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 19, 2010

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

US(3)