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Assessment of the Analgesic Effects of PF-06273340 in Healthy Volunteers Using Evoked Pain Endpoints

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ClinicalTrials.gov Identifier: NCT02260947
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06273340 Drug: Pregabalin Drug: Ibuprofen Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: PF-06273340
PF-06273340 50 mg
Experimental: 2 Drug: PF-06273340
PF-06273340 400 mg
Active Comparator: 3 Drug: Pregabalin
Pregabalin 300 mg
Active Comparator: 4 Drug: Ibuprofen
Ibuprofen 600 mg
Placebo Comparator: 5 Drug: Placebo
Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Thermal pain detection threshold [ Time Frame: 0.5 - 4 hours ]
  2. Ultra-violet light sensitized pain detection threshold [ Time Frame: 0.5 - 4 hours ]
  3. Pressure pain tolerance threshold [ Time Frame: 0.5 - 4 hours ]
  4. Electrical pain tolerance threshold [ Time Frame: 0.5 - 4 hours ]
  5. Cold pressor tolerance threshold [ Time Frame: 0.5 - 4 hours ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.5 - 10 hours ]
  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0.5 - 10 hours ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0.5 - 10 hours ]
  4. Electrical pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  5. Electrical pain area under the visual analogue scale pain curve [ Time Frame: 0.5 - 10 hours ]
  6. Electrical pain post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  7. Electrical pain post-cold pressor pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  8. Electrical pain post cold pressor pain tolerance threshold [ Time Frame: 0.5 - 10 hours ]
  9. Electrical pain post cold pressor area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  10. Electrical pain post cold pressor post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  11. Conditioned pain modulation response pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  12. Conditioned pain modulation pain tolerance threshold [ Time Frame: 0.5 - 10 hours ]
  13. Conditioned pain modulation area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  14. Condition pain modulation post test VAS [ Time Frame: 0.5 - 10 hours ]
  15. Pressure pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  16. Pressure pain area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  17. Pressure pain post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  18. Cold pressor pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  19. Cold pressor area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  20. Cold pressor post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  21. PF-06273340 half life [ Time Frame: 0.5 - 10 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260947


Locations
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Netherlands
Centre for Human Drug Research
Leiden, CL, Netherlands, 2333
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02260947    
Other Study ID Numbers: B5261005
2014-003553-34 ( EudraCT Number )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Ibuprofen
Pregabalin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs