Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
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
1 other identifier
interventional
19
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2014
Shorter than P25 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 2, 2015
September 1, 2015
5 months
December 5, 2013
September 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Finger tapping speed
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
12 hours
Secondary Outcomes (8)
Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
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)
0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Oral Clearance (CL/F)
0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Volume of Distribution (Vz/F)
0, 0.5, 1, 2, 4, 8, 12, 24 hours
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
- Daily L-dopa dose between 300 and 1200 mg.
- MBRS score \>1.
You may not qualify if:
- Surgical intervention for Parkinson's disease.
- History of troublesome dyskinesias.
- Any significant AXIS I psychiatric disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Pfizer Investigational Site
Aventura, Florida, 33180, United States
Pfizer Investigational Site
Baco Raton, Florida, 33486, United States
Pfizer Investigational Site
South Miami, Florida, 33143, United States
Pfizer Investigational Site
Bingham Farms, Michigan, 48025, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
March 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 2, 2015
Record last verified: 2015-09