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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: PF-06412562

• Registration Number: NCT02006290
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Study Start: 2014-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	PF-06412562	-

Primary Outcome Measures

Name	Time	Method
Finger tapping speed	12 hours	maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology

Secondary Outcome Measures

Name	Time	Method
Plasma Decay Half-Life (t1/2)	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.
Apparent Volume of Distribution (Vz/F)	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.
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	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").
Maximum Observed Plasma Concentration (Cmax)	0, 0.5, 1, 2, 4, 5,8,12, 24 hours
Apparent Oral Clearance (CL/F)	0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)	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)	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)
Mean Residence Time (MRT)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Raleigh, North Carolina, United States