Parkinson's DiseasePhase 1NCT02006290
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
A Phase 1 study testing PF-06412562 in people with Parkinson's Disease, run by Pfizer at 5 sites in United States.
Trial summary
The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PF-06412562
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2014to Aug 2014
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
- Daily L-dopa dose between 300 and 1200 mg.
- MBRS score >1.
Who cannot join
- Surgical intervention for Parkinson's disease.
- History of troublesome dyskinesias.
- Any significant AXIS I psychiatric disease.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Baco Raton, Florida, 33486
Pfizer Investigational Site
Bingham Farms, Michigan, 48025
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease
The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.
- Conditions
- Parkinson's Disease
- Being tested
- PF-06412562, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06412562Drug
single oral split dose 30+20 mg QD
PlaceboDrug
tablet, matching placebo, QD
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PF-06412562 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger tapping speed
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
Measured: 12 hours
Secondary outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Oral Clearance (CL/F)
Measured: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Volume of Distribution (Vz/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Plasma Decay Half-Life (t1/2)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Mean Residence Time (MRT)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT02006290
- Sponsor's protocol ID
- B7441003
- Status last verified
- Sep 2015
- First submitted
- 5 Dec 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02006290
- Acronym / sponsor ID
- B7441003
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Dec 2013 (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 B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PF-06412562 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
- Daily L-dopa dose between 300 and 1200 mg.
- MBRS score >1.
Key exclusion criteria (3 listed)
- Surgical intervention for Parkinson's disease.
- History of troublesome dyskinesias.
- Any significant AXIS I psychiatric disease.
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-06412562single oral split dose 30+20 mg QD | Drug | 1 |
| Placebotablet, matching placebo, QD | Drug | 2 |
Primary outcome
Finger tapping speed
Time frame: 12 hours
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
8 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Oral Clearance (CL/F)
Time frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Volume of Distribution (Vz/F)
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Mean Residence Time (MRT)
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 24 hours
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 2 Oct 2015.
- 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
5 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-06412562 in people with Parkinson's Disease, run by Pfizer at 5 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 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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Finger tapping speed (time frame: 12 hours). 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 2 Oct 2015.