PainPhase 1NCT01511497
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
A Phase 1 study testing PF-04427429 and Normal saline in people with Pain and Migraine Disorders, run by Pfizer at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Migraine Disorders
- What is being tested?
- PF-04427429 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2011to Jan 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 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 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
- Women of childbearing potential.
- History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
Dallas, Texas, 75247
Pfizer Investigational Site
Miami, Florida, 33126
Pfizer Investigational Site
Miami, Florida, 33134
About this study
Official title: A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
- Conditions
- Pain, Migraine Disorders
- Being tested
- PF-04427429, Normal saline
- Keywords
- Phase 1, PF-04427429
- Medical subject headings
- Pain, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04427429Biological
Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.
Normal salineOther
Intravenous, normal saline
| Study group | Role | What they receive |
|---|---|---|
| PF-04427429 | Experimental | Not described Receives: Biological: PF-04427429 |
| Placebo | Placebo comparator | Normal saline Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
Measured: Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
Measured: Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
Measured: Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
Measured: Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
Measured: From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
Measured: Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
Measured: Screening up to Day 168
Mean change from baseline and placebo in body temperature.
Measured: Screening up to Day 168
Secondary outcomes (7)
Area under the concentration-time curve from zero to infinite time postdose (AUCinf).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Time to maximum concentration (Tmax).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Maximum concentration (Cmax).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Terminal elimination half-life (t½).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Clearance (CL).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Volume of distribution (Vz).
Measured: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT01511497
- Sponsor's protocol ID
- B0141008
- Status last verified
- Feb 2013
- First submitted
- 18 Oct 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Female Adult Volunteers
- ClinicalTrials.gov ID
- NCT01511497
- Acronym / sponsor ID
- B0141008
- Conditions
- Pain, Migraine Disorders
- Keywords
- Phase 1, PF-04427429
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Jan 2012 (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 determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04427429 | Experimental | Biological: PF-04427429 |
| Placebo | Placebo comparator | Other: Normal salineNormal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generally healthy women, of non-child bearing potential, between the ages of 18 and 65 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 35.0 kg/m2; and a total body weight between 50 kg (110 lbs) and 120 kg (265 lbs) inclusive.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, or neurologic, disease. Subjects with asymptomatic, seasonal allergies at the time of dosing will not be excluded.
- Women of childbearing potential.
- History or diagnosis of ocular disease or conditions that would confound the assessment of ocular safety, such as diabetic retinopathy, uveitis, severe wet or dry AMD.
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-04427429Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg. | Biological | PF-04427429 |
| Normal salineIntravenous, normal saline | Other | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to Day 168
Incidence and severity of clinical laboratory abnormalities.
Time frame: Screening up to Day 168
Mean change from baseline and placebo in blood pressure (BP).
Time frame: Screening up to Day 168
Mean change from baseline in 12-lead electrocardiogram (ECG) parameters compared to baseline and placebo.
Time frame: Screening up to Day 168
Categorical summary of QTcF compared to baseline between dose groups and placebo.
Time frame: Screening up to Day 168
Anti-Drug Antibodies (ADA) responses.
Time frame: From Day 0 up to Day 168 and until levels return to baseline.
Intravenous (IV) injection site reactions.
Time frame: Day 1 post dose
Mean change from baseline and placebo in pulse rate (PR).
Time frame: Screening up to Day 168
Mean change from baseline and placebo in body temperature.
Time frame: Screening up to Day 168
7 secondary outcomes
Area under the concentration-time curve from zero to infinite time postdose (AUCinf).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Time to maximum concentration (Tmax).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Maximum concentration (Cmax).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Area under the concentration-time curve from zero to the last quantifiable concentration (AUClast).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Terminal elimination half-life (t½).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Clearance (CL).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
Volume of distribution (Vz).
Time frame: Days 1, 2, 3, 4, 7, 14, 28, 42, 56, 70, 84 & 168
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 Feb 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
3 sites 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 Normal saline in people with Pain and Migraine Disorders, run by Pfizer at 3 sites 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 2 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 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Screening up to Day 168). The study lists 9 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 21 Feb 2013.