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Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 1

Conditions

Healthy

Treatments

Other: Saline
Drug: PF-02545920
Other: Placebo
Other: Ketamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244880
A8241014

Details and patient eligibility

About

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.

Full description

The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.

Enrollment

4 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

4 participants in 4 patient groups, including a placebo group

Saline/PF-02545920
Experimental group
Description:
Treatments are co-administered
Treatment:
Other: Saline
Drug: PF-02545920
Other: Saline
Drug: PF-02545920
Ketamine/PF-02545920
Experimental group
Description:
Treatments are co-administered
Treatment:
Other: Ketamine
Other: Ketamine
Drug: PF-02545920
Drug: PF-02545920
Saline/Placebo
Placebo Comparator group
Description:
Treatments are co-administered
Treatment:
Other: Saline
Other: Placebo
Other: Placebo
Other: Saline
Ketamine/Placebo
Experimental group
Description:
Treatments are co-administered
Treatment:
Other: Ketamine
Other: Placebo
Other: Ketamine
Other: Placebo

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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