Idiopathic Parkinson DiseasePhase 1NCT02373072
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
A Phase 1 study testing PF-06649751 and Trimethobenzamide Hydrochloride in people with Idiopathic Parkinson Disease, run by Pfizer at 8 sites in 2 countries.
Trial summary
This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- PF-06649751 and Trimethobenzamide Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Mar 2015to Mar 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- L-DOPA-responsiveness
- Hoehn \& Yahr Stage II-III inclusive
- Experiencing motor fluctuations
- Stable daily dose of L-DOPA of at least 300 mg
- Females on non-childbearing potential and male subjects
Who cannot join
- History of troublesome dyskinesias
- History of surgical intervention for Parkinson's disease
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
Neurology Consultants of Dallas, PA
Dallas, Texas, 75231
Walnut Hill Medical Center
Dallas, Texas, 75231
Parkinson's Movement Disorder Center of Maryland
Elkridge, Maryland, 21075
MD Clinical
Hallandale, Florida, 33009
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806
About this study
Official title: A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease
This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- PF-06649751, Trimethobenzamide Hydrochloride, Placebo
- Keywords
- Pakinson's Disease, Movement Disorders
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06649751Drug
Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg.
Trimethobenzamide HydrochlorideDrug
300mg TID, Capsules. Optional in both Cohorts.
PlaceboDrug
Subjects completing all three treatment periods will be receiving placebo once.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Receives: Drug: PF-06649751; Drug: Trimethobenzamide Hydrochloride; Drug: Placebo |
| Cohort 2 | Experimental | Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Receives: Drug: PF-06649751; Drug: Trimethobenzamide Hydrochloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of subjects with Adverse Events (AEs)
Measured: Day 1 through 61
Number of participants with vital signs data that meet criteria of potential clinical concern
Measured: Day 1 through 61
Number of participants with ECG data that meet criteria of potential clinical concern
Measured: Day 1 through 61
Number of participants with abnormal clinically significant laboratory measurements
Measured: Day 1 through 61
C-SSRS (suicidality assessment)
Measured: Day 1 through 61
Secondary outcomes (1)
MDS-UPDRS part III
MDS - Unified Parkinson's Disease Rating Scale Part III
Measured: Day 1, Periods 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT02373072
- Sponsor's protocol ID
- B7601009
- Other IDs
- 2014-004389-54, 2014
- Status last verified
- Jan 2017
- First submitted
- 20 Feb 2015
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018 Dec;7(2):307-319. doi: 10.1007/s40120-018-0114-z. Epub 2018 Oct 25.
PubMed 30361858
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02373072
- Acronym / sponsor ID
- B7601009
- Conditions
- Idiopathic Parkinson Disease
- Keywords
- Pakinson's Disease, Movement Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Feb 2015 (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 is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-06649751, Drug: Trimethobenzamide Hydrochloride, Drug: PlaceboThree single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. |
| Cohort 2 | Experimental | Drug: PF-06649751, Drug: Trimethobenzamide Hydrochloride, Drug: PlaceboThree single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- L-DOPA-responsiveness
- Hoehn \& Yahr Stage II-III inclusive
- Experiencing motor fluctuations
- Stable daily dose of L-DOPA of at least 300 mg
- Females on non-childbearing potential and male subjects
Key exclusion criteria (2 listed)
- History of troublesome dyskinesias
- History of surgical intervention for Parkinson's 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-06649751Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg. | Drug | Cohort 1, Cohort 2 |
| Trimethobenzamide Hydrochloride300mg TID, Capsules. Optional in both Cohorts. | Drug | Cohort 1, Cohort 2 |
| PlaceboSubjects completing all three treatment periods will be receiving placebo once. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Number and proportion of subjects with Adverse Events (AEs)
Time frame: Day 1 through 61
Number of participants with vital signs data that meet criteria of potential clinical concern
Time frame: Day 1 through 61
Number of participants with ECG data that meet criteria of potential clinical concern
Time frame: Day 1 through 61
Number of participants with abnormal clinically significant laboratory measurements
Time frame: Day 1 through 61
C-SSRS (suicidality assessment)
Time frame: Day 1 through 61
1 secondary outcome
MDS-UPDRS part III
Time frame: Day 1, Periods 1-3
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 22 Sep 2023.
- Derived from this study: PubMed 30361858Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018 Dec;7(2):307-319. doi: 10.1007/s40120-018-0114-z. Epub 2018 Oct 25.
- 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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06649751 and Trimethobenzamide Hydrochloride in people with Idiopathic Parkinson Disease, run by Pfizer at 8 sites in 2 countries.
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 2 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, 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?
Number and proportion of subjects with Adverse Events (AEs) (time frame: Day 1 through 61). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02373072, which also lists 1 linked publication.
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 Sep 2023.