Acute PainPhase 1NCT00836082
A Multiple Dose Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04457845 in Healthy Volunteers
A Phase 1 study testing PF-04457845, FAAH inhibitor in people with Acute Pain and Chronic Pain, run by Pfizer at 1 site in Singapore.
Trial summary
To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Chronic Pain
- What is being tested?
- PF-04457845, FAAH inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2009to Jul 2009
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects (of non childbearing potential) between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hyperlipidemia), pancreatic, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to the first dose.
- 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 men (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 30 days ( or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
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- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- Females of childbearing potential.
- Use of prescription or nonprescription drugs, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormonal replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, ibuprofen may be used at doses of up to 1800 mg/day with food. Limited use of non-prescription medications that are not believed to affect subject safety or overall results of the study may be permitted on a case -by-case basis following approval by the sponsor.
- Unwillingness to refrain from consumption of grapefruit or grapefruit/pomelo containing products within 7 days prior to the first dose of study medication until the completion of the follow-up visit.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- Subject is the Investigator or sub-Investigator. research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
- 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.
- The use of marijuana (or other illicit drugs) within 30 days of randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind (Sponsor Open), Randomised, Placebo-Controlled, Parallel Group, Oral Multiple-Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04457845 In Healthy Volunteers
To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg.
- Conditions
- Acute Pain, Chronic Pain
- Being tested
- PF-04457845, FAAH inhibitor
- Keywords
- Healthy volunteers
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04457845, FAAH inhibitorDrug
Oral solution of 0.5mg given once daily for 14 days.
PF-04457845, FAAH inhibitorDrug
Oral solution of 1mg given once daily for 14 days.
PF-04457845, FAAH inhibitorDrug
Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days.
PF-04457845, FAAH inhibitorDrug
A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
PF-04457845, FAAH inhibitorDrug
Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days.
PF-04457845, FAAH inhibitorDrug
A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 0.5mg per day for 14 days. Receives: Drug: PF-04457845, FAAH inhibitor |
| Cohort 2 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 1mg per day for 14 days. Receives: Drug: PF-04457845, FAAH inhibitor |
| Cohort 3 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 4mg per day for 14 days. Receives: Drug: PF-04457845, FAAH inhibitor |
| Cohort 4 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 8mg per day for 14 days. Receives: Drug: PF-04457845, FAAH inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the multiple-dose pharmacokinetics of PF-04457845.
Measured: 14 Days
To characterize the relationship between PF-04457845 and the level of anandamide and level of FAAH enzyme inhibition in healthy adult volunteers following multiple dosing.
Measured: 14 Days
To evaluate the safety and tolerability of multiple oral doses of PF-04457845.
Measured: 14 Days
To determine the effect on food on PF-04457845 pharmacokinetics following administration of single doses of 4mg and 8mg.
Measured: 7-14 Days
To determine the effect on food on PF-04457845 safety following administration of single doses of 4mg and 8mg.
Measured: 7-14 Days
Secondary outcomes (3)
CogState/GMLT
Measured: 14 Days
Telemetry
Measured: 14 Days
Neurologic Exam
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836082
- Sponsor's protocol ID
- B0541002
- Status last verified
- Aug 2009
- First submitted
- 12 Jan 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind (Sponsor Open), Randomised, Placebo-Controlled, Parallel Group, Oral Multiple-Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04457845 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00836082
- Acronym / sponsor ID
- B0541002
- Conditions
- Acute Pain, Chronic Pain
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Feb 2009 (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.
To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (N=10) | Experimental | Drug: PF-04457845, FAAH inhibitorPlacebo-controlled, escalating multiple doses of 0.5mg per day for 14 days. |
| Cohort 2 (N=10) | Experimental | Drug: PF-04457845, FAAH inhibitorPlacebo-controlled, escalating multiple doses of 1mg per day for 14 days. |
| Cohort 3 (N=10) | Experimental | Drug: PF-04457845, FAAH inhibitorPlacebo-controlled, escalating multiple doses of 4mg per day for 14 days. |
| Cohort 4 (N=10) | Experimental | Drug: PF-04457845, FAAH inhibitorPlacebo-controlled, escalating multiple doses of 8mg per day for 14 days. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects (of non childbearing potential) between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (15 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hyperlipidemia), pancreatic, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- History of febrile illness within 5 days prior to the first dose.
- 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 men (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.
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-04457845, FAAH inhibitorOral solution of 0.5mg given once daily for 14 days. | Drug | Cohort 1 (N=10) |
| PF-04457845, FAAH inhibitorOral solution of 1mg given once daily for 14 days. | Drug | Cohort 2 (N=10) |
| PF-04457845, FAAH inhibitorOral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days. | Drug | Cohort 3 (N=10) |
| PF-04457845, FAAH inhibitorA randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase | Drug | Cohort 3 (N=10) |
| PF-04457845, FAAH inhibitorOral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days. | Drug | Cohort 4 (N=10) |
| PF-04457845, FAAH inhibitorA randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase | Drug | Cohort 4 (N=10) |
Primary outcome
To characterize the multiple-dose pharmacokinetics of PF-04457845.
Time frame: 14 Days
To characterize the relationship between PF-04457845 and the level of anandamide and level of FAAH enzyme inhibition in healthy adult volunteers following multiple dosing.
Time frame: 14 Days
To evaluate the safety and tolerability of multiple oral doses of PF-04457845.
Time frame: 14 Days
To determine the effect on food on PF-04457845 pharmacokinetics following administration of single doses of 4mg and 8mg.
Time frame: 7-14 Days
To determine the effect on food on PF-04457845 safety following administration of single doses of 4mg and 8mg.
Time frame: 7-14 Days
3 secondary outcomes
CogState/GMLT
Time frame: 14 Days
Telemetry
Time frame: 14 Days
Neurologic Exam
Time frame: 14 Days
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 6 Aug 2009.
- 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-04457845, FAAH inhibitor in people with Acute Pain and Chronic Pain, run by Pfizer at 1 site in Singapore.
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 4 inclusion and 15 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 6 Aug 2009. 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 Singapore. 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?
To characterize the multiple-dose pharmacokinetics of PF-04457845. (time frame: 14 Days). 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 6 Aug 2009.