HealthyPhase 1NCT01147432
Acute Response Capsaicin Flare Study
A Phase 1 study testing PF-04427429 and Capsaicin challenge in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04427429 and Capsaicin challenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2010to Oct 2011
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 50 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.
- 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 trial.
- Skintype I-III with a distance from base of scaphoid to antecubital fossa >26cm on their forearms.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
- Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.
- 12-lead ECG demonstrating QTcF >450 msec at screening.
- Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control
Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.
Read the detailed description
Proof of mechanism in healthy volunteers
- Conditions
- Healthy
- Being tested
- PF-04427429, Capsaicin challenge, Placebo, EMLA positive control
- Keywords
- Healthy male volunteers, capsaicin challenge, safety, toleration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04427429Drug
Single dose IV infusion up to 300mg
Capsaicin challengeOther
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
PlaceboDrug
Placebo IV infusion (saline) to be administered during two of the three treatment periods
Capsaicin challengeOther
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
EMLA positive controlOther
2g EMLA cream to be applied ONCE during study period 1
| Study group | Role | What they receive |
|---|---|---|
| PF-04427429 | Experimental | Not described Receives: Drug: PF-04427429; Other: Capsaicin challenge |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Capsaicin challenge |
| EMLA | Active comparator | Not described Receives: Other: EMLA positive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Measured: 7 weeks post first dose
Secondary outcomes (4)
Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety
Measured: 12 weeks post final dose
Plasma concentrations of free PF-04427429
Measured: 6 weekly following week 15
Plasma concentrations of free and total CGRP
Measured: 6 weekly following week 15
Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.
Measured: 7 weeks post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT01147432
- Sponsor's protocol ID
- B0141006
- Status last verified
- Dec 2011
- First submitted
- 16 Jun 2010
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control
- ClinicalTrials.gov ID
- NCT01147432
- Acronym / sponsor ID
- B0141006
- Conditions
- Healthy
- Keywords
- Healthy male volunteers, capsaicin challenge, safety, toleration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 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.
Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.
Detailed description
Proof of mechanism in healthy volunteers
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PF-04427429 | Experimental | Drug: PF-04427429, Other: Capsaicin challenge |
| Placebo | Placebo comparator | Drug: Placebo, Other: Capsaicin challenge |
| EMLA | Active comparator | Other: EMLA positive control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between the ages of 18 and 50 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.
- 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 trial.
- Skintype I-III with a distance from base of scaphoid to antecubital fossa >26cm on their forearms.
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
- Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.
- 12-lead ECG demonstrating QTcF >450 msec at screening.
- Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.
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-04427429Single dose IV infusion up to 300mg | Drug | PF-04427429 |
| Capsaicin challengeCapsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period | Other | PF-04427429 |
| PlaceboPlacebo IV infusion (saline) to be administered during two of the three treatment periods | Drug | Placebo |
| Capsaicin challengeCapsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period | Other | Placebo |
| EMLA positive control2g EMLA cream to be applied ONCE during study period 1 | Other | EMLA |
Primary outcome
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Time frame: 7 weeks post first dose
4 secondary outcomes
Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety
Time frame: 12 weeks post final dose
Plasma concentrations of free PF-04427429
Time frame: 6 weekly following week 15
Plasma concentrations of free and total CGRP
Time frame: 6 weekly following week 15
Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.
Time frame: 7 weeks post first dose
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 21 Dec 2011.
- 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-04427429 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 3 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 21 Dec 2011. 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 induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin (time frame: 7 weeks post first dose). 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 21 Dec 2011.