HealthyPhase 1NCT01165723
A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
A Phase 1 study testing PF-04427429 in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 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
- 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
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2010to Jan 2012
- 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 non 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 50 to 100kg 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
Who cannot join
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
- 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 Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.
- Conditions
- Healthy
- Being tested
- PF-04427429
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04427429Biological
Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
PF-04427429Biological
Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
| Study group | Role | What they receive |
|---|---|---|
| IV Dose 1: experimental | Experimental | Not described Receives: Biological: PF-04427429 |
| IV Dose 2: experimental | Experimental | Not described Receives: Biological: 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: up to 129 days
Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions
Measured: up to 129 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: up to 129 days
Secondary outcomes (1)
pharmacodynamics (free and total CGRP plasma concentration) will be measured, the PK-PD relationship between plasma PF-0447429 concentrations and free/total CGRP concentrations will be characterised
Measured: up to 129 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- NCT01165723
- Sponsor's protocol ID
- B0141007
- Status last verified
- Feb 2012
- First submitted
- 16 Jul 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses PF-04427429 Administered Intravenously To Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01165723
- Acronym / sponsor ID
- B0141007
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics, pharmacodynamics, chronic pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Jul 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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Dose 1: experimental | Experimental | Biological: PF-04427429 |
| IV Dose 2: experimental | Experimental | Biological: PF-04427429 |
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 non 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 50 to 100kg 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
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
- 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-04427429Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30 | Biological | IV Dose 1: experimental |
| PF-04427429Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30 | Biological | IV Dose 2: experimental |
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: up to 129 days
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: up to 129 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: up to 129 days
1 secondary outcome
pharmacodynamics (free and total CGRP plasma concentration) will be measured, the PK-PD relationship between plasma PF-0447429 concentrations and free/total CGRP concentrations will be characterised
Time frame: up to 129 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 22 Feb 2012.
- 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, 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 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 22 Feb 2012. 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. 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: up to 129 days). 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 22 Feb 2012.