A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
NCT ID: NCT02373072
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2015-03-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1
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.
PF-06649751
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 Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
Placebo
Subjects completing all three treatment periods will be receiving placebo once.
Cohort 2
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.
PF-06649751
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 Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
Placebo
Subjects completing all three treatment periods will be receiving placebo once.
Interventions
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PF-06649751
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 Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
Placebo
Subjects completing all three treatment periods will be receiving placebo once.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of surgical intervention for Parkinson's disease
30 Years
85 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Collaborative Neuroscience Network, LLC.
Long Beach, California, United States
MD Clinical
Hallandale, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States
Parkinson's Movement Disorder Center of Maryland
Elkridge, Maryland, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, United States
Walnut Hill Medical Center
Dallas, Texas, United States
Pfizer Clinical Research Unit
Brussels, , Belgium
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-004389-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7601009
Identifier Type: -
Identifier Source: org_study_id
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