HealthyPhase 1NCT02349607
Assessment of the Analgesic Effects of PF-05089771 and Pregabalin in Healthy Volunteers Using Evoked Pain Endpoints
A Phase 1 study testing PF-05089771 300mg, PF-05089771 300 mg + pregabalin 300 mg and pregabalin 300 mg in people with Healthy, run by Pfizer at 1 site in Netherlands.
Trial summary
This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-05089771 300mg, PF-05089771 300 mg + pregabalin 300 mg and pregabalin 300 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Mar 2015
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects 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 or clinical laboratory tests. •Body Mass Index (BMI) of 17.5 to 30.5 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 has been informed of all pertinent aspects of the study. •Subjects who are willing and able to comply with all 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, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). •Any condition possibly affecting drug absorption (eg, gastrectomy). •A positive urine drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Double Dummy, Randomized, Placebo-controlled, 5 Period Cross-over Study To Examine The Effect Of Pf-05089771 Alone And In Combination With Pregabalin On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls
This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
- Conditions
- Healthy
- Being tested
- PF-05089771 300mg, PF-05089771 300 mg + pregabalin 300 mg, Placebo, pregabalin 300 mg, ibuprofen 600 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05089771 300mgDrug
PF-05089771 300 mg
PF-05089771 300 mg + pregabalin 300 mgDrug
PF-05089771 300 mg + pregabalin 300 mg
PlaceboDrug
Placeco
pregabalin 300 mgDrug
pregabalin 300 mg
ibuprofen 600 mgDrug
ibuprofen 600 mg
| Study group | Role | What they receive |
|---|---|---|
| PF-05089771 300 mg | Experimental | Not described Receives: Drug: PF-05089771 300mg |
| PF-05089771 300 mg + pregabalin 300 mg | Experimental | Not described Receives: Drug: PF-05089771 300 mg + pregabalin 300 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| pregabalin 300 mg | Active comparator | Not described Receives: Drug: pregabalin 300 mg |
| ibuprofen 600 mg | Active comparator | Not described Receives: Drug: ibuprofen 600 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal pain detection threshold
Measured: 1-10 hours
Ultra-violet light sensitized pain detection threshold
Measured: 1-10 hours
Pressure pain tolerance threshold
Measured: 1-10 hours
Electrical pain tolerance threshold
Measured: 1-10 hours
Cold pressor tolerance threshold
Measured: 1-10 hours
Secondary outcomes (22)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0.5-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0.5-10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0.5-10
Electrical pain detection threshold
Measured: 0.5-10 hours
Electrical pain area under the visual analogue scale pain curve
Measured: 0.5-10 hours
Electrical pain post test visual analogue scale
Measured: 0.5-10 hours
Electrical pain post-cold pressor pain detection threshold
Measured: 0.5-10 hours
Electrical pain post cold pressor pain tolerance threshold
Measured: 0.5-10 hours
Electrical pain post cold pressor area under the visual analogue scale curve
Measured: 0.5-10 hours
Electrical pain post cold pressor post test visual analogue scale
Measured: 0.5-10 hours
Conditioned pain modulation response pain detection threshold
Measured: 0.5-10 hours
Conditioned pain modulation pain tolerance threshold
Measured: 0.5-10 hours
Conditioned pain modulation area under the visual analogue scale curve
Measured: 0.5-10 hours
Condition pain modulation post test VAS
Measured: 0.5-10 hours
Pressure pain detection threshold
Measured: 0.5-10 hours
Pressure pain area under the visual analogue scale curve
Measured: 0.5-10 hours
Pressure pain post test visual analogue scale
Measured: 0.5-10 hours
Cold pressor pain detection threshold
Measured: 0.5-10 hours
Cold pressor area under the visual analogue scale curve
Measured: 0.5-10 hours
Cold pressor post test visual analogue scale
Measured: 0.5-10 hours
PF-05089771 half life
Measured: 0.5-10 hours
Pregabalin half life
Measured: 0.5-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 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
- NCT02349607
- Sponsor's protocol ID
- B3291010
- Other IDs
- 2014-004468-39, 2014
- Status last verified
- Apr 2015
- First submitted
- 23 Jan 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Double Dummy, Randomized, Placebo-controlled, 5 Period Cross-over Study To Examine The Effect Of Pf-05089771 Alone And In Combination With Pregabalin On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls
- ClinicalTrials.gov ID
- NCT02349607
- Acronym / sponsor ID
- B3291010
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jan 2015 (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.
This study will examine the activity of PF-05089771 and pregabalin, alone and in combination on a panel of evoked pain tests carried out from 0.5 to 10 hours following oral dosing in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF-05089771 300 mg | Experimental | Drug: PF-05089771 300mg |
| PF-05089771 300 mg + pregabalin 300 mg | Experimental | Drug: PF-05089771 300 mg + pregabalin 300 mg |
| Placebo | Placebo comparator | Drug: Placebo |
| pregabalin 300 mg | Active comparator | Drug: pregabalin 300 mg |
| ibuprofen 600 mg | Active comparator | Drug: ibuprofen 600 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects 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 or clinical laboratory tests. •Body Mass Index (BMI) of 17.5 to 30.5 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 has been informed of all pertinent aspects of the study. •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (1 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 the time of dosing). •Any condition possibly affecting drug absorption (eg, gastrectomy). •A positive urine drug screen
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-05089771 300mgPF-05089771 300 mg | Drug | PF-05089771 300 mg |
| PF-05089771 300 mg + pregabalin 300 mgPF-05089771 300 mg + pregabalin 300 mg | Drug | PF-05089771 300 mg + pregabalin 300 mg |
| PlaceboPlaceco | Drug | Placebo |
| pregabalin 300 mgpregabalin 300 mg | Drug | pregabalin 300 mg |
| ibuprofen 600 mgibuprofen 600 mg | Drug | ibuprofen 600 mg |
Primary outcome
Thermal pain detection threshold
Time frame: 1-10 hours
Ultra-violet light sensitized pain detection threshold
Time frame: 1-10 hours
Pressure pain tolerance threshold
Time frame: 1-10 hours
Electrical pain tolerance threshold
Time frame: 1-10 hours
Cold pressor tolerance threshold
Time frame: 1-10 hours
22 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0.5-10
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0.5-10
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0.5-10
Electrical pain detection threshold
Time frame: 0.5-10 hours
Electrical pain area under the visual analogue scale pain curve
Time frame: 0.5-10 hours
Electrical pain post test visual analogue scale
Time frame: 0.5-10 hours
Electrical pain post-cold pressor pain detection threshold
Time frame: 0.5-10 hours
Electrical pain post cold pressor pain tolerance threshold
Time frame: 0.5-10 hours
Electrical pain post cold pressor area under the visual analogue scale curve
Time frame: 0.5-10 hours
Electrical pain post cold pressor post test visual analogue scale
Time frame: 0.5-10 hours
Conditioned pain modulation response pain detection threshold
Time frame: 0.5-10 hours
Conditioned pain modulation pain tolerance threshold
Time frame: 0.5-10 hours
Conditioned pain modulation area under the visual analogue scale curve
Time frame: 0.5-10 hours
Condition pain modulation post test VAS
Time frame: 0.5-10 hours
Pressure pain detection threshold
Time frame: 0.5-10 hours
Pressure pain area under the visual analogue scale curve
Time frame: 0.5-10 hours
Pressure pain post test visual analogue scale
Time frame: 0.5-10 hours
Cold pressor pain detection threshold
Time frame: 0.5-10 hours
Cold pressor area under the visual analogue scale curve
Time frame: 0.5-10 hours
Cold pressor post test visual analogue scale
Time frame: 0.5-10 hours
PF-05089771 half life
Time frame: 0.5-10 hours
Pregabalin half life
Time frame: 0.5-10 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 23 Apr 2015.
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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 300mg, PF-05089771 300 mg + pregabalin 300 mg and pregabalin 300 mg in people with Healthy, run by Pfizer at 1 site in Netherlands.
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 1 inclusion and 1 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 23 Apr 2015. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Thermal pain detection threshold (time frame: 1-10 hours). 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 23 Apr 2015.