A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
Status: | Completed |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 85 |
Updated: | 6/17/2016 |
Start Date: | March 2015 |
End Date: | March 2016 |
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.
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.
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
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