PainPhase 1NCT01529671
A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Otseoarthritis Of The Knee
A Phase 1 study testing PF-05089771 in people with Pain, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- PF-05089771
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PF-05089771
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05089771Drug
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771Drug
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771Drug
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771Drug
PF-05089771 will be dosed as a suspension twice daily (BID)
PF-05089771Drug
PF-05089771 will be dosed as a suspension BID
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Experimental intervention: PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetics (PK) of PF-05089771. Receives: Drug: PF-05089771 |
| Cohort 2: Experimental intervention: PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. Receives: Drug: PF-05089771 |
| Cohort 3: Experimental intervention: PF-05089771 or placebo | Experimental | 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. Receives: Drug: PF-05089771 |
| Cohort 4: Experimental intervention: PF-05089771 or placebo | Experimental | Elderly Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. Receives: Drug: PF-05089771 |
| Cohort 5: Experimental intervention: PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. Receives: Drug: PF-05089771 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability of PF-05089771
Measured: Days 1-16
Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
Measured: Days 1, 4 and 14
Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
Measured: Days 1, 6 and 14
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
Measured: Days 1, 6 and 14
Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose
Measured: day 14 PK samples collected only for 48 hours
Secondary outcomes (6)
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
Measured: Days 14, over 48 hours of PK samples collection
Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS).
Measured: Days 14, every day over 24 hours
Daily time to ascend and descend stairs.
Measured: Days 14, every day over 24 hours
Daily pain following stair climbing and descending
Measured: Days 14, every day over 24 hours
Daily time for self paced walk
Measured: Days 14, every day over 24 hours
Daily pain following self paced walk.
Measured: Days 14, every day over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529671
- Sponsor's protocol ID
- B3291011
- Status last verified
- Dec 2012
- First submitted
- 6 Feb 2012
- Last updated
- 12 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01529671
- Acronym / sponsor ID
- B3291011
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Experimental intervention: PF-05089771 or placebo | Experimental | Drug: PF-05089771Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetics (PK) of PF-05089771. |
| Cohort 2: Experimental intervention: PF-05089771 or placebo | Experimental | Drug: PF-05089771Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. |
| Cohort 3: Experimental intervention: PF-05089771 or placebo | Experimental | Drug: PF-05089771Subjects 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. |
| Cohort 4: Experimental intervention: PF-05089771 or placebo | Experimental | Drug: PF-05089771Elderly Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. |
| Cohort 5: Experimental intervention: PF-05089771 or placebo | Experimental | Drug: PF-05089771Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-05089771PF-05089771 will be dosed as a suspension twice daily (BID) | Drug | Cohort 1: Experimental intervention: PF-05089771 or placebo |
| PF-05089771PF-05089771 will be dosed as a suspension twice daily (BID) | Drug | Cohort 2: Experimental intervention: PF-05089771 or placebo |
| PF-05089771PF-05089771 will be dosed as a suspension twice daily (BID) | Drug | Cohort 3: Experimental intervention: PF-05089771 or placebo |
| PF-05089771PF-05089771 will be dosed as a suspension twice daily (BID) | Drug | Cohort 4: Experimental intervention: PF-05089771 or placebo |
| PF-05089771PF-05089771 will be dosed as a suspension BID | Drug | Cohort 5: Experimental intervention: PF-05089771 or placebo |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-05089771 in people with Pain, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 (time frame: Days 1-16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.