HealthyPhase 1NCT01797796
Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
A Phase 1 study testing PF-06305591 and Capsaicin challenge in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare. 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-06305591 and Capsaicin challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2013to Jul 2013
- 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 Caucasian subjects with skin type I-III inclusive (Fitzpatrick Scale), 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).
- An informed consent document signed and dated by the subject.
- Subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms.
- Subjects who demonstrate a capsaicin -mediated neurogenic flare with a value >200 on the arbitrary Laser Doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at Screening.
Who cannot join
- Evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms.
- History of febrile illness within 5 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Cross-Over Study To Examine The Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare In Healthy Volunteers
The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
- Conditions
- Healthy
- Being tested
- PF-06305591, Capsaicin challenge, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06305591Drug
150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.
Capsaicin challengeOther
110 mg capsaicin cream (Axsain®) will be applied topically at each visit.
PlaceboDrug
Placebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.
Capsaicin challengeOther
110 mg capsaicin cream (Axsain®) will be applied topically at each visit.
| Study group | Role | What they receive |
|---|---|---|
| PF-06305591 | Experimental | Not described Receives: Drug: PF-06305591; Other: Capsaicin challenge |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Capsaicin challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood perfusion (calculated as area under the effect curve [AUEC]) between 40 and 60 minutes post administration of capsaicin in the 3 cm x 3 cm area of capsaicin application.
Measured: 1 day
Secondary outcomes (12)
Mean blood perfusion (calculated as AUEC), between 40 and 60 minutes post administration of capsaicin in the 12 cm x 5 cm area of laser Doppler scanning.
Measured: 1 day
Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Measured: 1 day
Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.
Measured: 1 day
Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Measured: 1 day
Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.
Measured: 1 day
Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Measured: 1 day
Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.
Measured: 1 day
Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Measured: 1 day
Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.
Measured: 1 day
Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) 30-60 minutes post topical application of capsaicin cream.
Measured: 1 day
Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) immediately following the first and second application of the heat stimulus.
Measured: 1 day
Plasma level of PF 06305591.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionJul 2013
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
- 16 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
- NCT01797796
- Sponsor's protocol ID
- B5281005
- Status last verified
- Aug 2013
- First submitted
- 21 Feb 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Cross-Over Study To Examine The Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01797796
- Acronym / sponsor ID
- B5281005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Feb 2013 (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 this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-06305591 | Experimental | Drug: PF-06305591, Other: Capsaicin challenge |
| Placebo | Placebo comparator | Drug: Placebo, Other: Capsaicin challenge |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male Caucasian subjects with skin type I-III inclusive (Fitzpatrick Scale), 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).
- An informed consent document signed and dated by the subject.
- Subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms.
- Subjects who demonstrate a capsaicin -mediated neurogenic flare with a value >200 on the arbitrary Laser Doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at Screening.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms.
- History of febrile illness within 5 days prior to dosing.
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-06305591150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once. | Drug | PF-06305591 |
| Capsaicin challenge110 mg capsaicin cream (Axsain®) will be applied topically at each visit. | Other | PF-06305591 |
| PlaceboPlacebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once. | Drug | Placebo |
| Capsaicin challenge110 mg capsaicin cream (Axsain®) will be applied topically at each visit. | Other | Placebo |
Primary outcome
Mean blood perfusion (calculated as area under the effect curve [AUEC]) between 40 and 60 minutes post administration of capsaicin in the 3 cm x 3 cm area of capsaicin application.
Time frame: 1 day
12 secondary outcomes
Mean blood perfusion (calculated as AUEC), between 40 and 60 minutes post administration of capsaicin in the 12 cm x 5 cm area of laser Doppler scanning.
Time frame: 1 day
Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Time frame: 1 day
Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.
Time frame: 1 day
Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Time frame: 1 day
Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.
Time frame: 1 day
Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Time frame: 1 day
Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.
Time frame: 1 day
Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.
Time frame: 1 day
Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.
Time frame: 1 day
Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) 30-60 minutes post topical application of capsaicin cream.
Time frame: 1 day
Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) immediately following the first and second application of the heat stimulus.
Time frame: 1 day
Plasma level of PF 06305591.
Time frame: 2 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 20 Aug 2013.
- 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-06305591 and Capsaicin challenge 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 4 inclusion and 3 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 20 Aug 2013. 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. 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?
Mean blood perfusion (calculated as area under the effect curve [AUEC]) between 40 and 60 minutes post administration of capsaicin in the 3 cm x 3 cm area of capsaicin application. (time frame: 1 day). 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 20 Aug 2013.