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Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints

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ClinicalTrials.gov Identifier: NCT02238717
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 4, 2014
First Posted Date  ICMJE September 12, 2014
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
  • Thermal pain detection threshold [ Time Frame: 0.5 - 6 hours ]
  • Ultra-violet light sensitized pain detection threshold [ Time Frame: 0.5 - 6 hours ]
  • Pressure pain tolerance threshold [ Time Frame: 0.5 - 6 hours ]
  • Electrical pain tolerance threshold [ Time Frame: 0.5 - 6 hours ]
  • Cold pressor tolerance threshold [ Time Frame: 0.5 - 6 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.5 - 10 hours ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0.5 - 10 hours ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain area under the visual analogue scale pain curve [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain post-cold pressor pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain post cold pressor pain tolerance threshold [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain post cold pressor area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  • Electrical pain post cold pressor post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  • Conditioned pain modulation response pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  • Conditioned pain modulation pain tolerance threshold [ Time Frame: 0.5 - 10 hours ]
  • Conditioned pain modulation area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  • Condition pain modulation post test VAS [ Time Frame: 0.5 - 10 hours ]
  • Pressure pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  • Pressure pain area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  • Pressure pain post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  • Cold pressor pain detection threshold [ Time Frame: 0.5 - 10 hours ]
  • Cold pressor area under the visual analogue scale curve [ Time Frame: 0.5 - 10 hours ]
  • Cold pressor post test visual analogue scale [ Time Frame: 0.5 - 10 hours ]
  • PF-06372865 half life [ Time Frame: 0.5 - 10 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints
Official Title  ICMJE A Double Blind, Double Dummy, Randomized, Placebo-controlled, 4 Period Cross-over Study To Examine The Effect Of Pf-06372865 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin As A Positive Control
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06372865 (65mg)
    single oral dose (65 mg)
  • Drug: PF-06372865 (15mg)
    single oral dose (15mg)
  • Drug: Pregabalin
    single oral dose (300mg)
  • Drug: Placebo
    matching oral placebo
Study Arms  ICMJE
  • Experimental: PF-06372865 (65mg)
    Intervention: Drug: PF-06372865 (65mg)
  • Experimental: PF-06372865 (15mg)
    Intervention: Drug: PF-06372865 (15mg)
  • Active Comparator: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02238717
Other Study ID Numbers  ICMJE B7431003
2014-003015-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP