Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints
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
2 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 4, 2015
February 1, 2015
2 months
October 6, 2014
February 2, 2015
Conditions
Outcome Measures
Primary Outcomes (5)
Thermal pain detection threshold
0.5 - 4 hours
Ultra-violet light sensitized pain detection threshold
0.5 - 4 hours
Pressure pain tolerance threshold
0.5 - 4 hours
Electrical pain tolerance threshold
0.5 - 4 hours
Cold pressor tolerance threshold
0.5 - 4 hours
Secondary Outcomes (21)
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
- +16 more secondary outcomes
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATOR4
ACTIVE COMPARATOR5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Centre for Human Drug Research
Leiden, CL, 2333, Netherlands
Related Publications (1)
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.
PMID: 29178434DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 4, 2015
Record last verified: 2015-02