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A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Otseoarthritis Of The Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01529671
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 6, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date December 12, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2012)
  • Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [ Time Frame: Days 1-16 ]
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1, 4 and 14 ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1, 6 and 14 ]
  • AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: Days 1, 6 and 14 ]
  • Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose [ Time Frame: day 14 PK samples collected only for 48 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
  • Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [ Time Frame: Days 1-16 ]
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1-16 ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1-16 ]
  • AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: Days 1-16 ]
  • Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose [ Time Frame: Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose ]
Change History Complete list of historical versions of study NCT01529671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: Days 14, over 48 hours of PK samples collection ]
  • Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS). [ Time Frame: Days 14, every day over 24 hours ]
  • Daily time to ascend and descend stairs. [ Time Frame: Days 14, every day over 24 hours ]
  • Daily pain following stair climbing and descending [ Time Frame: Days 14, every day over 24 hours ]
  • Daily time for self paced walk [ Time Frame: Days 14, every day over 24 hours ]
  • Daily pain following self paced walk. [ Time Frame: Days 14, every day over 24 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2012)
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: Days 14-16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Otseoarthritis Of The Knee
Official Title  ICMJE An Investigator And Subject Blinded, Sponsor Open, Randomized, Placebo Controlled, Multiple Dose Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of Pf-05089771 In Healthy Subjects And In Subjects With Osteoarthritis Of The Knee
Brief Summary The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: PF-05089771
    PF-05089771 will be dosed as a suspension twice daily (BID)
  • Drug: PF-05089771
    PF-05089771 will be dosed as a suspension BID
Study Arms  ICMJE
  • Experimental: Cohort 1: Experimental intervention: PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetics (PK) of PF-05089771.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 2: Experimental intervention: PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 3: Experimental intervention: PF-05089771 or placebo
    Subjects with osteoarthritis of the knee will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 4: Experimental intervention: PF-05089771 or placebo
    Elderly Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 5: Experimental intervention: PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771.
    Intervention: Drug: PF-05089771
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: December 10, 2012)
80
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2012)
85
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
  • elderly cohort : healthy male and/or female subjects of 65 and 74 years,
  • cohort 3: subjects with osteoarthritis of the knee: Male or female subjects not of child bearing potential between the ages of 18 and 75 years inclusive at the time of entering the study.

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 (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (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 or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
  • 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.
  • 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) or more 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.

for cohort 3: Evidence of relapse or recurrence of clinically significant endocrine, metabolic, pulmonary, hepatic, osteo-mio-artricular, gastrointestinal, cardiovascular, renal, , psychiatric or neurological disease, or neurological disease less than 28 days prior to screening.

Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee. History of diseases other than OA that may involve the index knee in the last 12 months prior to screening, including but not limited to: inflammatory joint diseases (i.e rehumatoid arthritis and gout), calcium crystal diseases, bursitis, tendinitis, tumors and cysts, ligament injuries, bone fractures, post-infective pathologies; widespread chronic pain conditions (ie, fibromyalgia) and neuropathic disorders.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529671
Other Study ID Numbers  ICMJE B3291011
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 2012

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