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.

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

We found this trial at

sites

SNBL Clinical Pharmacology Center

Baltimore, Maryland 21201

from

Baltimore, MD