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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01529671
First received: February 6, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: PF-05089771
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [ Time Frame: Days 1-16 ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1, 4 and 14 ] [ Designated as safety issue: No ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1, 6 and 14 ] [ Designated as safety issue: No ]
  • AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: Days 1, 6 and 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS). [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]
  • Daily time to ascend and descend stairs. [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]
  • Daily pain following stair climbing and descending [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]
  • Daily time for self paced walk [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]
  • Daily pain following self paced walk. [ Time Frame: Days 14, every day over 24 hours ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: PF-05089771
PF-05089771 will be dosed as a suspension twice daily (BID)
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.
Drug: PF-05089771
PF-05089771 will be dosed as a suspension twice daily (BID)
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.
Drug: PF-05089771
PF-05089771 will be dosed as a suspension twice daily (BID)
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.
Drug: PF-05089771
PF-05089771 will be dosed as a suspension twice daily (BID)
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.
Drug: PF-05089771
PF-05089771 will be dosed as a suspension BID

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529671

Locations
Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01529671     History of Changes
Other Study ID Numbers: B3291011
Study First Received: February 6, 2012
Last Updated: December 10, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014