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Completed

NCT Number: NCT02006290

Efficacy, Safety And Tolerability Study 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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Aventura, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-06412562

Drug

single oral split dose 30+20 mg QD

Placebo

Drug

tablet, matching placebo, QD

Primary outcomes

  1. Finger tapping speed

    Time frame: 12 hours

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

Secondary outcomes

  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").

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2013
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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