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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease

NCT02373072

CompletedPhase 1

Sponsor: Pfizer

Conditions: Idiopathic Parkinson Disease

Interventions: PF-06649751, Trimethobenzamide Hydrochloride, Placebo

Countries: United States, Belgium

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (8)

Long Beach, California, United States
Hallandale, Florida, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Elkridge, Maryland, United States
Dallas, Texas, United States
Dallas, Texas, United States
Brussels, Belgium