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

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ClinicalTrials.gov Identifier: NCT02006290
Recruitment Status : Completed
First Posted : December 10, 2013
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: PF-06412562 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Finger tapping speed [ Time Frame: 12 hours ]
    maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 5,8,12, 24 hours ]
  2. 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 ]
  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  4. Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
  5. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
    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.

  6. Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
    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.

  7. Mean Residence Time (MRT) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  8. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours ]
    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").


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006290


Locations
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United States, Florida
Pfizer Investigational Site
Aventura, Florida, United States, 33180
Pfizer Investigational Site
Baco Raton, Florida, United States, 33486
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Michigan
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02006290     History of Changes
Other Study ID Numbers: B7441003
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases