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

Completed · Phase 1 · Has a placebo group

Conditions studied: Idiopathic Parkinson Disease

In brief

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.

Key facts

Study ID

NCT02373072

Run by

Pfizer

People needed

18

Starts

2015-03-01

Expected to finish

2016-03-01

Last updated by the study team

2023-09-22

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• History of troublesome dyskinesias
• History of surgical intervention for Parkinson's disease

Where it is running

• Collaborative Neuroscience Network, LLC. — Long Beach, California, United States
• MD Clinical — Hallandale, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• SNBL Clinical Pharmacology Center, Inc. — Baltimore, Maryland, United States
• Parkinson's Movement Disorder Center of Maryland — Elkridge, Maryland, United States
• Neurology Consultants of Dallas, PA — Dallas, Texas, United States
• Walnut Hill Medical Center — Dallas, Texas, United States
• Pfizer Clinical Research Unit — Brussels, Belgium

Full record on ClinicalTrials.gov

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