Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
Public ClinicalTrials.gov record NCT02224664. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson's Disease And Motor Fluctuations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02224664
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2014
- Primary completion
- Feb 29, 2016
- Completion
- Feb 29, 2016
- Last update posted
- Mar 26, 2017
2014 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | — |
| The Parkinson's and Movement Disorder Institute | Fountain Valley | California | 92708 | — |
| Collaborative Neuroscience Network, LLC | Long Beach | California | 90806 | — |
| Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | — |
| Davita Clinical Research Center | Lakewood | Colorado | 80228 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Compass Research, LLC | Orlando | Florida | 32806 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Massachusetts General Hospital -- FOR DRUG SHIPMENT ONLY | Boston | Massachusetts | 02114 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| PRA International | Marlton | New Jersey | 08053 | — |
| Carolina Phase I Research, LLC | Raleigh | North Carolina | 27612 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Neurology Consultants of Dallas, PA | Dallas | Texas | 75231 | — |
| Walnut Hill Medical Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02224664, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2017 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02224664 live on ClinicalTrials.gov.