MigrainePhase 1NCT01981499
A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults
A Phase 1 study testing PF-05180999, 120 mg MR PF-05180999 and 360 mg MR PF-05180999 in people with Migraine, run by Pfizer at 1 site in United States.
Trial summary
PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult 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
- Migraine
- What is being tested?
- PF-05180999, 120 mg MR PF-05180999 and 360 mg MR PF-05180999
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2014
- 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
- No history of clinically-relevant atopic or dermatological disease
- Positive reaction to intradermal injection of histamine
Who cannot join
- Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
- Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C
- Intolerance to intradermal histamine injection.
- Subjects with dark skin (Part B only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Saint Paul, Minnesota, 55114
About this study
Official title: A Phase 1, Placebo-Controlled, Crossover, Subject- And Investigator-Blind, Sponsor-Open Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of A Modified-Release Formulation Of PF-05180999 In Healthy Adult Subjects
PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.
- Conditions
- Migraine
- Being tested
- PF-05180999, Placebo, 120 mg MR PF-05180999, 360 mg MR PF-05180999, 10 mg cetirizine
- Keywords
- PF-05180999, safety, tolerability, pharmacokinetics, histamine, wheal, flare, migraine, PDE2
- Medical subject headings
- Migraine Disorders, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05180999Drug
Ascending single oral doses of 120, 240, and 420 mg modified-release tablets
PlaceboDrug
Placebo tablets
120 mg MR PF-05180999Drug
Single 120 mg dose administered as modified release formulation
360 mg MR PF-05180999Drug
Single 360 mg dose administered as modified release formulation
10 mg cetirizineDrug
Single 10 mg dose of cetirizine
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm A1 | Experimental | Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 Receives: Drug: PF-05180999 |
| Arm A2 | Placebo comparator | Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 relative to placebo Receives: Drug: Placebo |
| Arm B1 | Experimental | Part B of study to assess effects of PF-05180999 on histamine-induced wheal Receives: Drug: 120 mg MR PF-05180999 |
| Arm B2 | Experimental | Part B of study to assess effects of PF-05180999 on histamine-induced wheal Receives: Drug: 360 mg MR PF-05180999 |
| Arm B3 | Experimental | Positive control to ensure histamine-induced wheal assay integrity Receives: Drug: 10 mg cetirizine |
| Arm B4 | Experimental | Placebo control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration
Measured: 0-72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time when Cmax occurred
Measured: 0-72 hours post-dose
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measure of drug absorption and drug exposure
Measured: 0-72 hours post-dose
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Measure of drug absorption and drug exposure
Measured: 0-infinity hours post-dose
Plasma Half-Life (t1/2)
Time for the plasma concentration to decrease by one-half.
Measured: 0-72 hours post-dose
Area Under the Effect Curve (AUEC) for Histamine-Induced Wheal
Measure of drug effect
Measured: 2-12 hours post-dose
Secondary outcomes (2)
Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced wheal
Measures of drug effect
Measured: 0-72 hours post-dose
Area Under the Effect Curve (AUEC) for histamine-induced flare; Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced flare
Measures of drug effect
Measured: 0-72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: The trial was prematurely terminated on 01April2014 due to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- 31 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
- NCT01981499
- Sponsor's protocol ID
- B3441009
- Status last verified
- May 2014
- First submitted
- 5 Nov 2013
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled, Crossover, Subject- And Investigator-Blind, Sponsor-Open Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of A Modified-Release Formulation Of PF-05180999 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01981499
- Acronym / sponsor ID
- B3441009
- Conditions
- Migraine
- Keywords
- PF-05180999, safety, tolerability, pharmacokinetics, histamine, wheal, flare, migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was prematurely terminated on 01April2014 due to safety concerns.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Nov 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.
PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A1 | Experimental | Drug: PF-05180999Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 |
| Arm A2 | Placebo comparator | Drug: PlaceboPart A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 relative to placebo |
| Arm B1 | Experimental | Drug: 120 mg MR PF-05180999Part B of study to assess effects of PF-05180999 on histamine-induced wheal |
| Arm B2 | Experimental | Drug: 360 mg MR PF-05180999Part B of study to assess effects of PF-05180999 on histamine-induced wheal |
| Arm B3 | Experimental | Drug: 10 mg cetirizinePositive control to ensure histamine-induced wheal assay integrity |
| Arm B4 | Experimental | Drug: PlaceboPlacebo control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between the ages of 18 and 55 years
- No history of clinically-relevant atopic or dermatological disease
- Positive reaction to intradermal injection of histamine
Key exclusion criteria (4 listed)
- Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
- Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C
- Intolerance to intradermal histamine injection.
- Subjects with dark skin (Part B only).
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-05180999Ascending single oral doses of 120, 240, and 420 mg modified-release tablets | Drug | Arm A1 |
| PlaceboPlacebo tablets | Drug | Arm A2 |
| 120 mg MR PF-05180999Single 120 mg dose administered as modified release formulation | Drug | Arm B1 |
| 360 mg MR PF-05180999Single 360 mg dose administered as modified release formulation | Drug | Arm B2 |
| 10 mg cetirizineSingle 10 mg dose of cetirizine | Drug | Arm B3 |
| PlaceboPlacebo tablets | Drug | Arm B4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-72 hours post-dose
Maximum observed plasma concentration
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-72 hours post-dose
Time when Cmax occurred
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0-72 hours post-dose
Measure of drug absorption and drug exposure
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Time frame: 0-infinity hours post-dose
Measure of drug absorption and drug exposure
Plasma Half-Life (t1/2)
Time frame: 0-72 hours post-dose
Time for the plasma concentration to decrease by one-half.
Area Under the Effect Curve (AUEC) for Histamine-Induced Wheal
Time frame: 2-12 hours post-dose
Measure of drug effect
2 secondary outcomes
Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced wheal
Time frame: 0-72 hours post-dose
Area Under the Effect Curve (AUEC) for histamine-induced flare; Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced flare
Time frame: 0-72 hours post-dose
Results and safety
The study was stopped early (reason given: The trial was prematurely terminated on 01April2014 due to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- 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-05180999, 120 mg MR PF-05180999 and 360 mg MR PF-05180999 in people with Migraine, run by Pfizer at 1 site in United States.
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: stopped early, as of the sponsor's last update on 8 May 2014. 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 United States. 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 was stopped early (reason given: The trial was prematurely terminated on 01April2014 due to safety concerns.). Results are not available in the source record.
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?
Maximum Observed Plasma Concentration (Cmax) (time frame: 0-72 hours post-dose). The study lists 6 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 8 May 2014.