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

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

Tracking Information

• First Submitted Date: September 4, 2014
• First Posted Date: September 12, 2014
• Last Update Posted Date: December 16, 2014
• Study Start Date: September 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Analgesic Effects of PF-06372865 in Healthy Volunteers Using Evoked Pain Endpoints
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2014): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT02238717
• Other Study ID Numbers: B7431003; 2014-003015-12 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2014