A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT01259882
• Recruitment Status: Completed
• First Posted: December 14, 2010
• Last Update Posted: February 2, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 30, 2010
• First Posted Date: December 14, 2010
• Last Update Posted Date: February 2, 2012
• Study Start Date: December 2010
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2010)

• Number of participants with adverse events as a measure of safety and tolerability of PF-05089771. [ Time Frame: Days 1-3 ]
• Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1-3 ]
• Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1-3 ]
• AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) [ Time Frame: Days 1-3 ]
• MRT = Mean residence time of PF-05089771 in the body (hr) [ Time Frame: Days 1-3 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 13, 2010)

• Heat Pain Perception Threshold (HPPT). Measured by applying a heat thermode to the thigh for 1 minute at 47oC. HPPT will be measured at 3 separate doses plus placebo in 12 healthy volunteers. [ Time Frame: Hours 1-6 post dose. ]
• Long Thermal Stimulation (LTS). Measured by applying a heat thermode to the thigh at 48oC for 5 seconds. will be measured at 3 separate doses plus placebo in 12 healthy volunteers [ Time Frame: Hours 1-6 post dose. ]
• Odor threshold (Sniffin' Sticks). Measured with Sniffin Sticks. Will be measured at 3 separate doses plus placebo in 12 healthy volunteers [ Time Frame: Hours 1-6 post dose. ]
• Urine: Aet (amount excreted in urine), Aet% and CLr for selected doses dependent on the emerging pharmacokinetics of PF-05089771 where t = 24 hours. [ Time Frame: Up to 24 hours ]
• AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: Days 1-3 ]
• AUC24 = Area under the curve from the time of dosing to 24 hours post dose (ng.hr/mL) [ Time Frame: Days 1-3 ]
• CI/F = Clearance of PF-05089771 from plasma corrected for systemic compound availability (L/hr) [ Time Frame: Days 1-3 ]
• t½ = Elimination half life of PF-05089771 (hr) [ Time Frame: Days 1-3 ]
• C8 hour = concentration of PF-05089771 in the plasma 8 hours post dose (ng/mL) [ Time Frame: Days 1-3 ]

• 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: A Single Dose Escalation Study In Healthy Volunteers To Determine The Pharmacokinetics, Safety And Tolerability Of PF-05089771 In Healthy Volunteers
• Official Title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study To Investigate The Safety, Toleration, Pharmacokinetics And Exploratory Pharmacodynamics Of PF-05089771 In Healthy Volunteers
• Brief Summary: This is a two part study. The purpose of the first part is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following single escalating doses. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel biomarkers in healthy volunteers. The doses selected in Part B will have been administered previously in Part A of the study.
• 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: Treatment
• Condition: Pain

Intervention

• Drug: PF-05089771
  Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
• Drug: PF-05089771
  Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. In addition the exploratory pharmacodynamics of PF-05089771 will be investigated using novel biomarkers.
• Drug: PF-05089771
  Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.

Study Arms

• Experimental: Cohort 1: Experimental intervention: PF-05089771 or placebo
  Cohort 1
  Intervention: Drug: PF-05089771
• Experimental: Cohort 2: Experimental intervention: PF-05089771 or placebo
  Cohort 2
  Intervention: Drug: PF-05089771
• Experimental: Cohort 3: Experimental intervention: PF-05089771 or placebo
  Cohort 3
  Intervention: Drug: PF-05089771
• Experimental: Cohort 4: Experimental intervention: PF-05089771 or placebo
  Cohort 4
  Intervention: Drug: PF-05089771
• Experimental: Cohort 5: Experimental intervention: PF-05089771 or placebo
  Cohort 5
  Intervention: Drug: PF-05089771
• Experimental: Cohort 6: Experimental intervention: PF-05089771 or placebo
  Cohort 6
  Intervention: Drug: PF-05089771

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2012): 61
• Original Estimated Enrollment (submitted: December 13, 2010): 32
• Actual Study Completion Date: September 2011
• Actual Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject
• Subjects who are willing and able to comply with 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 time of dosing).
• Any condition possibly affecting drug absorption (e.g., gastrectomy).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
• Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
• Females of child bearing potential.
• Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
• Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Sex/Gender

• Sexes Eligible for Study: All

• 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: Belgium

Administrative Information

• NCT Number: NCT01259882
• Other Study ID Numbers: B3291001
• 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: January 2012