Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints

Study Overview
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Brief Summary
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This study will examine the activity of 2 different doses of PF-06372865 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects.

Official Title
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A Double Blind, Double Dummy, Randomized, Placebo-controlled, 4 Period Cross-over Study To Examine The Effect Of Pf-06372865 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin As A Positive Control

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06372865 (65mg)
* Drug: PF-06372865 (15mg)
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 55 years, inclusive. 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 or clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06372865 (65mg)<br> | Drug: PF-06372865 (65mg)<br>* single oral dose (65 mg)<br>|
| Experimental: PF-06372865 (15mg)<br> | Drug: PF-06372865 (15mg)<br>* single oral dose (15mg)<br>|
| Active Comparator: Pregabalin<br> | Drug: Pregabalin<br>* single oral dose (300mg)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* matching oral placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thermal pain detection threshold |  | 0.5 - 6 hours | 
| Ultra-violet light sensitized pain detection threshold |  | 0.5 - 6 hours | 
| Pressure pain tolerance threshold |  | 0.5 - 6 hours | 
| Electrical pain tolerance threshold |  | 0.5 - 6 hours | 
| Cold pressor tolerance threshold |  | 0.5 - 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0.5 - 10 hours | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0.5 - 10 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0.5 - 10 hours | 
| 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-06372865 half life |  | 0.5 - 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, evoked pain, healthy volunteer, pharmacodynamics