Healthy
Conditions
Keywords
Pain, evoked pain, healthy volunteer, pharmacodynamics
Brief summary
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.
Interventions
DRUGPF-06372865 (65mg)
single oral dose (65 mg)
DRUGPF-06372865 (15mg)
single oral dose (15mg)
DRUGPregabalin
single oral dose (300mg)
DRUGPlacebo
matching oral placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 |
| Electrical pain post cold pressor pain tolerance threshold | 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 |
| Condition pain modulation post test VAS | 0.5 - 10 hours |
| 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 |
Countries
Netherlands
Outcome results
None listed