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Trial record 1 of 1 for:    NCT02006290
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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

Tracking Information
First Submitted Date  ICMJE December 5, 2013
First Posted Date  ICMJE December 10, 2013
Last Update Posted Date October 2, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
Finger tapping speed [ Time Frame: 12 hours ]
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02006290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 5,8,12, 24 hours ]
  • 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 ]
  • 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)
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
  • 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.
  • 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.
  • 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.
  • 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").
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2013)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
  • 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 ]
  • 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)
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours ]
  • 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.
  • 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.
  • 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.
  • 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").
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: PF-06412562
    single oral split dose 30+20 mg QD
  • Drug: Placebo
    tablet, matching placebo, QD
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: PF-06412562
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2015)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2013)
18
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02006290
Other Study ID Numbers  ICMJE B7441003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP