HealthyPhase 1NCT01103726
Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects
A Phase 1 study testing PF-02545920 in people with Healthy, run by Pfizer at 3 sites in United States.
Trial summary
We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum. 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-02545920
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Nov 2011
- 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
- Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
- An informed consent document signed and dated by the subject
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Women of reproductive potential
- History of agranulocytosis or movement disorder
- Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pfizer Investigational Site
New Haven, Connecticut, 06511
Pfizer Investigational Site
New Haven, Connecticut, 06519
Pfizer Investigational Site
New Haven, Connecticut, 06520
About this study
Official title: Evaluation Of Regional Glucose Metabolism In Striatum As Measured By [18f]-Fluorodeoxyglucose Positron Emission Tomography Following Single Oral Dose Administration Of PF-02545920 In Healthy Subjects
We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.
- Conditions
- Healthy
- Being tested
- PF-02545920, placebo
- Keywords
- FDG-PET, regional cerebral glucose metabolism, striatum, PDE10 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-02545920Drug
1 and 5 mg tablets, 6 mg single dose
placeboDrug
matching placebo tablets, single dose
PF-02545920Drug
1 mg tablets, 3 mg single dose
PF-02545920Drug
5 mg tablets, 15 mg single dose
PlaceboDrug
matching placebo tablets, single dose
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 | Experimental | Not described Receives: Drug: PF-02545920; Drug: placebo |
| Stage 2 | Experimental | Not described Receives: Drug: PF-02545920; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Secondary outcomes (7)
Whole brain glucose metabolic rate.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate.
Measured: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103726
- Sponsor's protocol ID
- A8241013
- Status last verified
- Nov 2011
- First submitted
- 13 Apr 2010
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Regional Glucose Metabolism In Striatum As Measured By [18f]-Fluorodeoxyglucose Positron Emission Tomography Following Single Oral Dose Administration Of PF-02545920 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01103726
- Acronym / sponsor ID
- A8241013
- Conditions
- Healthy
- Keywords
- FDG-PET, regional cerebral glucose metabolism, striatum, PDE10 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Apr 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.
We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 | Experimental | Drug: PF-02545920, Drug: placebo |
| Stage 2 | Experimental | Drug: PF-02545920, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
- An informed consent document signed and dated by the subject
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (3 listed)
- Women of reproductive potential
- History of agranulocytosis or movement disorder
- Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications
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-025459201 and 5 mg tablets, 6 mg single dose | Drug | Stage 1 |
| placebomatching placebo tablets, single dose | Drug | Stage 1 |
| PF-025459201 mg tablets, 3 mg single dose | Drug | Stage 2 |
| PF-025459205 mg tablets, 15 mg single dose | Drug | Stage 2 |
| Placebomatching placebo tablets, single dose | Drug | Stage 2 |
Primary outcome
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
7 secondary outcomes
Whole brain glucose metabolic rate.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate.
Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
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 16 Nov 2011.
- 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-02545920 in people with Healthy, 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 4 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 16 Nov 2011. 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. 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?
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method. (time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.). 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 16 Nov 2011.