Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease

A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease

The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: PF-06412562; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • Pfizer Investigational Site
    • Baco Raton, Florida, United States, 33486
      • Pfizer Investigational Site
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
• Daily L-dopa dose between 300 and 1200 mg.
• MBRS score >1.

Exclusion Criteria:

• Surgical intervention for Parkinson's disease.
• History of troublesome dyskinesias.
• Any significant AXIS I psychiatric disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: PF-06412562; single oral split dose 30+20 mg QD
Placebo Comparator: 2	Drug: Placebo; tablet, matching placebo, QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger tapping speed	maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Oral Clearance (CL/F)		0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Apparent Volume of Distribution (Vz/F)	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.	0, 0.5, 1, 2, 4, 8, 12, 24 hours
Plasma Decay Half-Life (t1/2)	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.	0, 0.5, 1, 2, 4, 8, 12, 24 hours
Mean Residence Time (MRT)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0, 0.5, 1, 2, 4, 8, 12, 24 hours
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").	24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 5, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 10, 2013

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: September 30, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: B7441003