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

NCT ID: NCT01529671

Last Updated: 2012-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

PF-05089771

Intervention Type: DRUG

PF-05089771 will be dosed as a suspension twice daily (BID)

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.

Group Type: EXPERIMENTAL

PF-05089771

Intervention Type: DRUG

PF-05089771 will be dosed as a suspension twice daily (BID)

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.

Group Type: EXPERIMENTAL

PF-05089771

Intervention Type: DRUG

PF-05089771 will be dosed as a suspension twice daily (BID)

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.

Group Type: EXPERIMENTAL

PF-05089771

Intervention Type: DRUG

PF-05089771 will be dosed as a suspension twice daily (BID)

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.

Group Type: EXPERIMENTAL

PF-05089771

Intervention Type: DRUG

PF-05089771 will be dosed as a suspension BID

Interventions

PF-05089771

PF-05089771 will be dosed as a suspension twice daily (BID)

Intervention Type: DRUG

PF-05089771

PF-05089771 will be dosed as a suspension twice daily (BID)

Intervention Type: DRUG

PF-05089771

PF-05089771 will be dosed as a suspension twice daily (BID)

Intervention Type: DRUG

PF-05089771

PF-05089771 will be dosed as a suspension twice daily (BID)

Intervention Type: DRUG

PF-05089771

PF-05089771 will be dosed as a suspension BID

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Brussels, , Belgium

Countries

Belgium

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3291011&StudyName=A%20Safety%20And%20Tolerability%20Study%20Of%20PF-05089771%20In%20Healthy%20Subjects%20And%20In%20Subjects%20With%20Otseoarthritis%20Of%20The%20Knee

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Other Identifiers

B3291011

Identifier Type: -

Identifier Source: org_study_id