Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Inclusion Criteria:

• Females of non-childbearing potential and/or male subjects
• Clinical diagnosis of Parkinson's disease.
• Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
• Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
• Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

• History or presence of atypical Parkinsonian syndrome.
• Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
• Any condition possibly affecting drug absorption.
• Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.