Clinical trial NCT02260947: Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints
Official title: A Double Blind, Double Dummy, Randomized, Placebocontrolled, 5 Period Cross-over Study To Examine The Effect of Pf-06273340 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the activity of 2 different doses of PF-06273340 on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects


Eligibility criteria: 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

Primary outcomes:
measure: Thermal pain detection threshold
timeFrame: 0.5 - 4 hours
measure: Ultra-violet light sensitized pain detection threshold
timeFrame: 0.5 - 4 hours
measure: Pressure pain tolerance threshold
timeFrame: 0.5 - 4 hours
measure: Electrical pain tolerance threshold
timeFrame: 0.5 - 4 hours
measure: Cold pressor tolerance threshold
timeFrame: 0.5 - 4 hours
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.5 - 10 hours
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0.5 - 10 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0.5 - 10 hours
measure: Electrical pain detection threshold
timeFrame: 0.5 - 10 hours
measure: Electrical pain area under the visual analogue scale pain curve
timeFrame: 0.5 - 10 hours
measure: Electrical pain post test visual analogue scale
timeFrame: 0.5 - 10 hours
measure: Electrical pain post-cold pressor pain detection threshold
timeFrame: 0.5 - 10 hours
measure: Electrical pain post cold pressor pain tolerance threshold
timeFrame: 0.5 - 10 hours
measure: Electrical pain post cold pressor area under the visual analogue scale curve
timeFrame: 0.5 - 10 hours
measure: Electrical pain post cold pressor post test visual analogue scale
timeFrame: 0.5 - 10 hours
measure: Conditioned pain modulation response pain detection threshold
timeFrame: 0.5 - 10 hours
measure: Conditioned pain modulation pain tolerance threshold
timeFrame: 0.5 - 10 hours
measure: Conditioned pain modulation area under the visual analogue scale curve
timeFrame: 0.5 - 10 hours
measure: Condition pain modulation post test VAS
timeFrame: 0.5 - 10 hours
measure: Pressure pain detection threshold
timeFrame: 0.5 - 10 hours
measure: Pressure pain area under the visual analogue scale curve
timeFrame: 0.5 - 10 hours
measure: Pressure pain post test visual analogue scale
timeFrame: 0.5 - 10 hours
measure: Cold pressor pain detection threshold
timeFrame: 0.5 - 10 hours
measure: Cold pressor area under the visual analogue scale curve
timeFrame: 0.5 - 10 hours
measure: Cold pressor post test visual analogue scale
timeFrame: 0.5 - 10 hours
measure: PF-06273340 half life
timeFrame: 0.5 - 10 hours
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
state: CL
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Loudon P, Siebenga P, Gorman D, Gore K, Dua P, van Amerongen G, Hay JL, Groeneveld GJ, Butt RP. Demonstration of an anti-hyperalgesic effect of a novel pan-Trk inhibitor PF-06273340 in a battery of human evoked pain models. Br J Clin Pharmacol. 2018 Feb;84(2):301-309. doi: 10.1111/bcp.13448. Epub 2017 Nov 28.