HealthyPhase 1NCT01462851
A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults
A Phase 1 study testing PF-05297909 25 mg, PF-05297909 100 mg and PF-05297909 250 mg in people with Healthy, run by Pfizer at 2 sites in United States.
Trial summary
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-05297909 25 mg, PF-05297909 100 mg and PF-05297909 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
- Conditions
- Healthy
- Being tested
- PF-05297909 25 mg, PF-05297909 100 mg, PF-05297909 250 mg, PF-05297909 525 mg
- Keywords
- healthy volunteer, safety, pharmacokinetic, pharmacodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05297909 25 mgDrug
Single oral (PO) dose, PF-05297909 25 mg
PF-05297909 100 mgDrug
Single oral (PO) dose, PF-05297909 100 mg
PF-05297909 250 mgDrug
Single oral (PO) dose, PF-05297909 250 mg
PF-05297909 525 mgDrug
Single oral (PO) dose, PF-05297909 525 mg
PF-05297909 525 mgDrug
Single oral (PO) dose, 525 mg
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Ascending doses in healthy volunteers Receives: Drug: PF-05297909 25 mg; Drug: PF-05297909 100 mg; Drug: PF-05297909 250 mg; Drug: PF-05297909 525 mg |
| Part 2: CSF PKPD | Experimental | Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment Receives: Drug: PF-05297909 525 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma area under the curve last (AUClast) pharmacokinetic parameter
Measured: Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter
Measured: Day 0 to Day 3
Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model
Measured: Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
Measured: Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter
Measured: Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
Measured: Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.
Measured: Day 1 to Day 3
Change from baseline in CSF levels of Abeta40
Measured: Day 1 to Day 3
Change from baseline in CSF levels of Abeta42
Measured: Day 1 to Day 3
Change from baseline in CSF levels of AbetaX
Measured: Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha
Measured: Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 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
- NCT01462851
- Sponsor's protocol ID
- B3941001
- Status last verified
- Mar 2012
- First submitted
- 8 Sep 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01462851
- Acronym / sponsor ID
- B3941001
- Conditions
- Healthy
- Keywords
- healthy volunteer, safety, pharmacokinetic, pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Oct 2011 (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.
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: PF-05297909 25 mg, Drug: PF-05297909 100 mg, Drug: PF-05297909 250 mg, Drug: PF-05297909 525 mgAscending doses in healthy volunteers |
| Part 2: CSF PKPD | Experimental | Drug: PF-05297909 525 mgPharmacokinetic and pharmacodynamic cerebrospinal fluid assessment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
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-05297909 25 mgSingle oral (PO) dose, PF-05297909 25 mg | Drug | Dose Escalation |
| PF-05297909 100 mgSingle oral (PO) dose, PF-05297909 100 mg | Drug | Dose Escalation |
| PF-05297909 250 mgSingle oral (PO) dose, PF-05297909 250 mg | Drug | Dose Escalation |
| PF-05297909 525 mgSingle oral (PO) dose, PF-05297909 525 mg | Drug | Dose Escalation |
| PF-05297909 525 mgSingle oral (PO) dose, 525 mg | Drug | Part 2: CSF PKPD |
Primary outcome
Plasma area under the curve last (AUClast) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter
Time frame: Day 0 to Day 3
Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model
Time frame: Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
Time frame: Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of Abeta40
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of Abeta42
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of AbetaX
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.
Time frame: Day 1 to Day 3
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 13 Mar 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
2 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-05297909 25 mg, PF-05297909 100 mg and PF-05297909 250 mg in people with Healthy, run by Pfizer at 2 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 1 inclusion and 1 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 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Plasma area under the curve last (AUClast) pharmacokinetic parameter (time frame: Day 1 to Day 3). The study lists 12 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 13 Mar 2012.