Back to resultsA Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
Primary Purpose
Idiopathic Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-06649751
Trimethobenzamide Hydrochloride
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Idiopathic Parkinson Disease focused on measuring Pakinson's Disease, Movement Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of troublesome dyskinesias
- History of surgical intervention for Parkinson's disease
Sites / Locations
- Collaborative Neuroscience Network, LLC.
- MD Clinical
- Atlanta Center for Medical Research
- SNBL Clinical Pharmacology Center, Inc.
- Parkinson's Movement Disorder Center of Maryland
- Neurology Consultants of Dallas, PA
- Walnut Hill Medical Center
- Pfizer Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number and proportion of subjects with Adverse Events (AEs)
Number of participants with vital signs data that meet criteria of potential clinical concern
Number of participants with ECG data that meet criteria of potential clinical concern
Number of participants with abnormal clinically significant laboratory measurements
C-SSRS (suicidality assessment)
Secondary Outcome Measures
MDS-UPDRS part III
MDS - Unified Parkinson's Disease Rating Scale Part III
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02373072
Brief Title
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease
Keywords
Pakinson's Disease, Movement Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-06649751
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trimethobenzamide Hydrochloride
Intervention Description
300mg TID, Capsules. Optional in both Cohorts.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects completing all three treatment periods will be receiving placebo once.
Primary Outcome Measure Information:
Title
Number and proportion of subjects with Adverse Events (AEs)
Time Frame
Day 1 through 61
Title
Number of participants with vital signs data that meet criteria of potential clinical concern
Time Frame
Day 1 through 61
Title
Number of participants with ECG data that meet criteria of potential clinical concern
Time Frame
Day 1 through 61
Title
Number of participants with abnormal clinically significant laboratory measurements
Time Frame
Day 1 through 61
Title
C-SSRS (suicidality assessment)
Time Frame
Day 1 through 61
Secondary Outcome Measure Information:
Title
MDS-UPDRS part III
Description
MDS - Unified Parkinson's Disease Rating Scale Part III
Time Frame
Day 1, Periods 1-3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of troublesome dyskinesias
History of surgical intervention for Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
SNBL Clinical Pharmacology Center, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Parkinson's Movement Disorder Center of Maryland
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Neurology Consultants of Dallas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Walnut Hill Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pfizer Clinical Research Unit
City
Brussels
ZIP/Postal Code
B-1070
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
30361858
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7601009&StudyName=A%20Phase%201%2C%20Double%20Blind%2C%20Sponsor%20Open%2C%20Randomized%2C%20Placebo-controlled%2C%20Single%20Ascending%20Dose%20Study%20To%20Investigate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20Pf-06649751%20In%20Subjects%20With%20Idiopathic%20Parkinson%E2%80%99s%20Disease
Description
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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
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