Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02349607
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PF-05089771 300 mg PF-05089771 300mg - PF-05089771 300 mg + pregabalin 300 mg PF-05089771 300 mg + pregabalin 300 mg - Placebo Placebo - ibuprofen 600 mg ibuprofen 600 mg - pregabalin 300 mg pregabalin 300 mg -
- Primary Outcome Measures
Name Time Method Ultra-violet light sensitized pain detection threshold 1-10 hours Electrical pain tolerance threshold 1-10 hours Pressure pain tolerance threshold 1-10 hours Cold pressor tolerance threshold 1-10 hours Thermal pain detection threshold 1-10 hours
- Secondary Outcome Measures
Name Time Method Electrical pain post cold pressor post test visual analogue scale 0.5-10 hours Pregabalin half life 0.5-10 hours Pressure pain detection threshold 0.5-10 hours Electrical pain detection threshold 0.5-10 hours Time to Reach Maximum Observed Plasma Concentration (Tmax) 0.5-10 Electrical pain post test visual analogue scale 0.5-10 hours Pressure pain area under the visual analogue scale curve 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 Electrical pain post-cold pressor pain detection threshold 0.5-10 hours Conditioned pain modulation response pain detection threshold 0.5-10 hours Cold pressor post test visual analogue scale 0.5-10 hours Maximum Observed Plasma Concentration (Cmax) 0.5-10 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 0.5-10 Conditioned pain modulation pain tolerance threshold 0.5-10 hours Pressure pain post test visual analogue scale 0.5-10 hours PF-05089771 half life 0.5-10 hours Electrical pain area under the visual analogue scale pain curve 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 Cold pressor pain detection threshold 0.5-10 hours Cold pressor area under the visual analogue scale curve 0.5-10 hours
Trial Locations
- Locations (1)
Centre for Human Drug Research
🇳🇱Leiden, CL, Netherlands