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CompletedNCT01259882Updated Feb 2, 2012

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

A Phase 1 interventional study of PF-05089771 and PF-05089771 in Pain, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-02.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • Pharmacokinetics Safety Tolerability Pharmacodynamics
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Cohort 1: Experimental intervention: PF-05089771 or placebo

    Cohort 1

    Drug: PF-05089771

  • Experimental
    Cohort 2: Experimental intervention: PF-05089771 or placebo

    Cohort 2

    Drug: PF-05089771

  • Experimental
    Cohort 3: Experimental intervention: PF-05089771 or placebo

    Cohort 3

    Drug: PF-05089771

  • Experimental
    Cohort 4: Experimental intervention: PF-05089771 or placebo

    Cohort 4

    Drug: PF-05089771

  • Experimental
    Cohort 5: Experimental intervention: PF-05089771 or placebo

    Cohort 5

    Drug: PF-05089771

  • Experimental
    Cohort 6: Experimental intervention: PF-05089771 or placebo

    Cohort 6

    Drug: PF-05089771

Interventions

  • DrugPF-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.

  • DrugPF-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.

  • DrugPF-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.

  • DrugPF-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.

  • DrugPF-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.

  • DrugPF-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.

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability of PF-05089771.

    Time frame: Days 1-3

  2. Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)

    Time frame: Days 1-3

  3. Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)

    Time frame: Days 1-3

  4. AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)

    Time frame: Days 1-3

  5. MRT = Mean residence time of PF-05089771 in the body (hr)

    Time frame: Days 1-3

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)

    Time frame: Days 1-3

  6. AUC24 = Area under the curve from the time of dosing to 24 hours post dose (ng.hr/mL)

    Time frame: Days 1-3

  7. CI/F = Clearance of PF-05089771 from plasma corrected for systemic compound availability (L/hr)

    Time frame: Days 1-3

  8. t½ = Elimination half life of PF-05089771 (hr)

    Time frame: Days 1-3

  9. C8 hour = concentration of PF-05089771 in the plasma 8 hours post dose (ng/mL)

    Time frame: Days 1-3

07

Study locations

1 site
  • Pfizer Investigational Site
    Bruxelles, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01259882
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 14, 2010
Start date
Dec 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Feb 2, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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