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

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01529671
Pfizer
Completed
A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Otseoarthritis Of The Knee

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[email protected]

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