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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Trimethobenzamide

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