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See termination reason in detailed description.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline/PF-02545920 | Experimental | Treatments are co-administered |
|
| Ketamine/PF-02545920 | Experimental | Treatments are co-administered |
|
| Saline/Placebo | Placebo Comparator | Treatments are co-administered |
|
| Ketamine/Placebo | Experimental | Treatments are co-administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Other | Saline infusion for 56 minutes |
| |
| PF-02545920 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06510 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
PF-02545920 10 mg single dose |
|
| Ketamine | Other | Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes PF-02545920 10 mg tablet |
|
| PF-02545920 | Drug | PF-02545920 10 mg tablet single dose |
|
| Saline | Other | Saline infusion for 56 minutes |
|
| Placebo | Other | Placebo tablet single dose |
|
| Ketamine | Other | Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes |
|
| Placebo | Other | Placebo tablet single dose |
|
| 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 |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06520 | United States |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C545121 | 2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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