Healthy VolunteersPhase 1NCT01011296
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
A Phase 1 study testing PF-04427429 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers. 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 Volunteers
- What is being tested?
- PF-04427429
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 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 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).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
- 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.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.
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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of febrile illness within 5 days prior to the first dose.
- A positive urine drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group, First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
Read the detailed description
Phase 1 clinical trial
- Conditions
- Healthy Volunteers
- Being tested
- PF-04427429
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04427429Drug
Single 0.2mg dose of intravenous infusion
PF-04427429Drug
Single 1mg dose of intravenous infusion
PF-04427429Drug
Single 3 mg dose of intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Single IV Dose 1 | Experimental | Not described Receives: Drug: PF-04427429 |
| Single IV Dose 2 | Experimental | Not described Receives: Drug: PF-04427429 |
| Single IV Dose 3 | Experimental | Not described Receives: Drug: PF-04427429 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/ placebo)
Measured: anticipated time is up to 84 days post dose
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions)
Measured: anticipated time is up to 84 days post dose to 84 days
Pharmacokinetics (Free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)
Measured: anticipated time is up to 84 days post dose days
Secondary outcomes (1)
Pharmacodynamics (free and total CGRP plasma concentrations will be measured, the PK-PD relationship between plasma PF-04427429 concentrations and free/total CGRP concentrations will be characterized)
Measured: anticipated time is up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
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
- NCT01011296
- Sponsor's protocol ID
- B0141001
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2009
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group, First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01011296
- Acronym / sponsor ID
- B0141001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Nov 2009 (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 evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
Detailed description
Phase 1 clinical trial
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single IV Dose 1 | Experimental | Drug: PF-04427429 |
| Single IV Dose 2 | Experimental | Drug: PF-04427429 |
| Single IV Dose 3 | Experimental | Drug: PF-04427429 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
- 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.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.
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).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- History of febrile illness within 5 days prior to the first dose.
- A positive urine drug screen
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 0.2mg dose of intravenous infusion | Drug | Single IV Dose 1 |
| PF-04427429Single 1mg dose of intravenous infusion | Drug | Single IV Dose 2 |
| PF-04427429Single 3 mg dose of intravenous infusion | Drug | Single IV Dose 3 |
Primary outcome
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/ placebo)
Time frame: anticipated time is up to 84 days post dose
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions)
Time frame: anticipated time is up to 84 days post dose to 84 days
Pharmacokinetics (Free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)
Time frame: anticipated time is up to 84 days post dose days
1 secondary outcome
Pharmacodynamics (free and total CGRP plasma concentrations will be measured, the PK-PD relationship between plasma PF-04427429 concentrations and free/total CGRP concentrations will be characterized)
Time frame: anticipated time is up to 84 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 4 Dec 2018.
- 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 in people with Healthy Volunteers, 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 5 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 4 Dec 2018. 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. 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?
Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/ placebo) (time frame: anticipated time is up to 84 days post dose). The study lists 3 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 4 Dec 2018.