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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006290
• Other study ID #: B7441003
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2013
• Last updated: September 30, 2015
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• PF-06412562
single oral split dose 30+20 mg QD
• Placebo
tablet, matching placebo, QD

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Aventura	Florida
United States	Pfizer Investigational Site	Baco Raton	Florida
United States	Pfizer Investigational Site	Bingham Farms	Michigan
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finger tapping speed	maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology	12 hours	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 4, 5,8,12, 24 hours	Yes
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours	No
Secondary	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	No
Secondary	Apparent Oral Clearance (CL/F)		0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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