Clinical trial NCT02373072: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
Official title: A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Parkinson Disease
Keywords: Pakinson's Disease, Movement Disorders
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Number and proportion of subjects with Adverse Events (AEs)
timeFrame: Day 1 through 61
measure: Number of participants with vital signs data that meet criteria of potential clinical concern
timeFrame: Day 1 through 61
measure: Number of participants with ECG data that meet criteria of potential clinical concern
timeFrame: Day 1 through 61
measure: Number of participants with abnormal clinically significant laboratory measurements
timeFrame: Day 1 through 61
measure: C-SSRS (suicidality assessment)
timeFrame: Day 1 through 61
Secondary outcomes:
measure: MDS-UPDRS part III
timeFrame: Day 1, Periods 1-3
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center, Inc.
state: Maryland
city: Elkridge
country: United States
facility: Parkinson's Movement Disorder Center of Maryland
state: Maryland
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA
state: Texas
city: Dallas
country: United States
facility: Walnut Hill Medical Center
state: Texas
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018 Dec;7(2):307-319. doi: 10.1007/s40120-018-0114-z. Epub 2018 Oct 25.