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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06412562
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Finger tapping speed
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
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)
Apparent Oral Clearance (CL/F)
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.
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.
Mean Residence Time (MRT)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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").

Full Information

First Posted
December 5, 2013
Last Updated
September 30, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02006290
Brief Title
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-06412562
Intervention Description
single oral split dose 30+20 mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, matching placebo, QD
Primary Outcome Measure Information:
Title
Finger tapping speed
Description
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame
0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Apparent Oral Clearance (CL/F)
Time Frame
0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Apparent Volume of Distribution (Vz/F)
Description
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.
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Plasma Decay Half-Life (t1/2)
Description
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.
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Mean Residence Time (MRT)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
0, 0.5, 1, 2, 4, 8, 12, 24 hours
Title
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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").
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Pfizer Investigational Site
City
Baco Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Pfizer Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7441003
Description
To obtain contact information for a study center near you, click here.

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

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