Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease

Completed · Phase 1

Conditions studied: Parkinson's Disease

In brief

This study will be an open label, dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1 and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be modified based on emerging safety, tolerability and PK data, but the maximum daily dose that will be given in any cohort will have PK predictions at steady state that are anticipated to be below toxicokinetic limits. An option for down titration to the previous dose level is available should the investigator consider that an AE is intolerable. Following down titration, a single up titration to the next dose level may be attempted if the subject remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to initiating the dosing in Cohort 6.

Key facts

Study ID

NCT02224664

Run by

Pfizer

People needed

50

Starts

2014-10-01

Expected to finish

2016-03-01

Last updated by the study team

2017-03-27

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of idiopathic Parkinson's Disease with at least 2 out of 3 cardinal characteristics (tremor, rigidity, bradykinesia)
• Mini-Mental State Examination (MMSE) ≥ 25
• Hoehn \& Yahr Stage I-III inclusive
• Documented history of end of L-Dopa wearing OFF
• Cohort 5 only: History of dyskinesia following L-Dopa dosing and Score of at least 2 on Part IV, item 4.2 (functional impact of dyskinesia) of the MDS-UPDRS

You may not qualify if…

• Atypical/secondary parkinsonism
• History of surgical intervention for Parkinson's Disease
• Dementia/cognitive impairment that can interfere with study assessments

Where it is running

• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Collaborative Neuroscience Network, LLC — Long Beach, California, United States
• Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
• Davita Clinical Research Center — Lakewood, Colorado, United States
• MD Clinical — Hallandale, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Massachusetts General Hospital -- FOR DRUG SHIPMENT ONLY — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• PRA International — Marlton, New Jersey, United States
• Carolina Phase I Research, LLC — Raleigh, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, 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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