A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
- Conditions
- Idiopathic Parkinson Disease
- Interventions
- Registration Number
- NCT02373072
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- History of troublesome dyskinesias
- History of surgical intervention for Parkinson's disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Trimethobenzamide Hydrochloride Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Cohort 1 Placebo Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Cohort 2 Placebo Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Cohort 1 Trimethobenzamide Hydrochloride Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Cohort 2 PF-06649751 Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week. Cohort 1 PF-06649751 Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
- Primary Outcome Measures
Name Time Method Number of participants with abnormal clinically significant laboratory measurements Day 1 through 61 Number and proportion of subjects with Adverse Events (AEs) Day 1 through 61 Number of participants with vital signs data that meet criteria of potential clinical concern Day 1 through 61 Number of participants with ECG data that meet criteria of potential clinical concern Day 1 through 61 C-SSRS (suicidality assessment) Day 1 through 61
- Secondary Outcome Measures
Name Time Method MDS-UPDRS part III Day 1, Periods 1-3 MDS - Unified Parkinson's Disease Rating Scale Part III
Trial Locations
- Locations (8)
Walnut Hill Medical Center
🇺🇸Dallas, Texas, United States
Collaborative Neuroscience Network, LLC.
🇺🇸Long Beach, California, United States
Parkinson's Movement Disorder Center of Maryland
🇺🇸Elkridge, Maryland, United States
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium
SNBL Clinical Pharmacology Center, Inc.
🇺🇸Baltimore, Maryland, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Neurology Consultants of Dallas, PA
🇺🇸Dallas, Texas, United States