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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004468-39 | EudraCT Number |
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This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05089771 300 mg | Experimental |
| |
| PF-05089771 300 mg + pregabalin 300 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| pregabalin 300 mg | Active Comparator |
| |
| ibuprofen 600 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 300mg | Drug | PF-05089771 300 mg |
| |
| PF-05089771 300 mg + pregabalin 300 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal pain detection threshold | 1-10 hours | |
| Ultra-violet light sensitized pain detection threshold | 1-10 hours | |
| Pressure pain tolerance threshold | 1-10 hours | |
| Electrical pain tolerance threshold | 1-10 hours | |
| Cold pressor tolerance threshold | 1-10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 0.5-10 | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0.5-10 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | CL | 2333 | Netherlands |
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| ID | Term |
|---|---|
| C000618268 | PF-05089771 |
| D000069583 | Pregabalin |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Drug |
PF-05089771 300 mg + pregabalin 300 mg |
|
| Placebo | Drug | Placeco |
|
| pregabalin 300 mg | Drug | pregabalin 300 mg |
|
| ibuprofen 600 mg | Drug | ibuprofen 600 mg |
|
| 0.5-10 |
| Electrical pain detection threshold | 0.5-10 hours |
| Electrical pain area under the visual analogue scale pain curve | 0.5-10 hours |
| Electrical pain post test visual analogue scale | 0.5-10 hours |
| Electrical pain post-cold pressor pain detection threshold | 0.5-10 hours |
| Electrical pain post cold pressor pain tolerance threshold | 0.5-10 hours |
| Electrical pain post cold pressor area under the visual analogue scale curve | 0.5-10 hours |
| Electrical pain post cold pressor post test visual analogue scale | 0.5-10 hours |
| Conditioned pain modulation response pain detection threshold | 0.5-10 hours |
| Conditioned pain modulation pain tolerance threshold | 0.5-10 hours |
| Conditioned pain modulation area under the visual analogue scale curve | 0.5-10 hours |
| Condition pain modulation post test VAS | 0.5-10 hours |
| Pressure pain detection threshold | 0.5-10 hours |
| Pressure pain area under the visual analogue scale curve | 0.5-10 hours |
| Pressure pain post test visual analogue scale | 0.5-10 hours |
| Cold pressor pain detection threshold | 0.5-10 hours |
| Cold pressor area under the visual analogue scale curve | 0.5-10 hours |
| Cold pressor post test visual analogue scale | 0.5-10 hours |
| PF-05089771 half life | 0.5-10 hours |
| Pregabalin half life | 0.5-10 hours |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |