HealthyPhase 1NCT01127906
Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
A Phase 1 study testing PF-04531083 100mg, PF-04531083 2000mg and Oxycodone 20mg in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man. 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-04531083 100mg, PF-04531083 2000mg and Oxycodone 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2010to Sep 2010
- 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 volunteers.
- Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.
Who cannot join
- Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
- 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.
- Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
- Subjects with inadequate or excessive sensitivity to UVB light.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers
PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.
- Conditions
- Healthy
- Being tested
- PF-04531083 100mg, PF-04531083 2000mg, Placebo suspension, Placebo tablet, Oxycodone 20mg
- Keywords
- Healthy Volunteers, cross-over, randomized, placebo and active controlled, heat pain, UVB-Induced pain model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04531083 100mgDrug
Oral PF-04531083 100mg suspension single dose
PF-04531083 2000mgDrug
Oral PF-04531083 2000mg suspension single dose
Placebo suspensionDrug
Oral Placebo suspension (matched to PF-04531083 suspension)
Placebo tabletDrug
Oral Placebo tablet (matched to Oxycodone)
Oxycodone 20mgDrug
Oral Oxycodone 20mg (Oxycontin) controlled release formulation
| Study group | Role | What they receive |
|---|---|---|
| Randomized cross-over sequence | Other | Randomized unbalanced sequence of incomplete block design with replicates within sequence Receives: Drug: PF-04531083 100mg; Drug: PF-04531083 2000mg; Drug: Placebo suspension; Drug: Placebo tablet; Drug: Oxycodone 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.
Measured: 24 hours
Secondary outcomes (4)
Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.
Measured: 24 hours
Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours
Measured: 24 hours
Summary of plasma concentrations of PF-04531083
Measured: 24 hours
Exploratory colorimetric data collected from baseline and MED test exposure areas
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT01127906
- Sponsor's protocol ID
- B1351003
- Status last verified
- Sep 2010
- First submitted
- 20 May 2010
- Last updated
- 23 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01127906
- Acronym / sponsor ID
- B1351003
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, cross-over, randomized, placebo and active controlled, heat pain, UVB-Induced pain model
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 May 2010 (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.
PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomized cross-over sequence | Other | Drug: PF-04531083 100mg, Drug: PF-04531083 2000mg, Drug: Placebo suspension, Drug: Placebo tablet, Drug: Oxycodone 20mgRandomized unbalanced sequence of incomplete block design with replicates within sequence |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers.
- Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.
Key exclusion criteria (4 listed)
- Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
- 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.
- Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
- Subjects with inadequate or excessive sensitivity to UVB light.
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-04531083 100mgOral PF-04531083 100mg suspension single dose | Drug | Randomized cross-over sequence |
| PF-04531083 2000mgOral PF-04531083 2000mg suspension single dose | Drug | Randomized cross-over sequence |
| Placebo suspensionOral Placebo suspension (matched to PF-04531083 suspension) | Drug | Randomized cross-over sequence |
| Placebo tabletOral Placebo tablet (matched to Oxycodone) | Drug | Randomized cross-over sequence |
| Oxycodone 20mgOral Oxycodone 20mg (Oxycontin) controlled release formulation | Drug | Randomized cross-over sequence |
Primary outcome
To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.
Time frame: 24 hours
4 secondary outcomes
Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.
Time frame: 24 hours
Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours
Time frame: 24 hours
Summary of plasma concentrations of PF-04531083
Time frame: 24 hours
Exploratory colorimetric data collected from baseline and MED test exposure areas
Time frame: 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 23 Sep 2010.
- 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-04531083 100mg, PF-04531083 2000mg and Oxycodone 20mg in people with Healthy, 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 2 inclusion and 4 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 Sep 2010. 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?
To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours. (time frame: 24 hours). 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 Sep 2010.