A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease

Idiopathic Parkinson Disease Clinical Trial

Official title:

A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373072
• Other study ID #: B7601009
• Secondary ID: 2014-004389-54
• Status: Completed
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

Inclusion Criteria:

• L-DOPA-responsiveness

• Hoehn & Yahr Stage II-III inclusive

• Experiencing motor fluctuations

• Stable daily dose of L-DOPA of at least 300 mg

• Females on non-childbearing potential and male subjects

Exclusion Criteria:

• History of troublesome dyskinesias

• History of surgical intervention for Parkinson's disease

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

Intervention

Drug:
• PF-06649751
Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg.
• Trimethobenzamide Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
• Placebo
Subjects completing all three treatment periods will be receiving placebo once.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	SNBL Clinical Pharmacology Center, Inc.	Baltimore	Maryland
United States	Neurology Consultants of Dallas, PA	Dallas	Texas
United States	Walnut Hill Medical Center	Dallas	Texas
United States	Parkinson's Movement Disorder Center of Maryland	Elkridge	Maryland
United States	MD Clinical	Hallandale Beach	Florida
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and proportion of subjects with Adverse Events (AEs)		Day 1 through 61
Primary	Number of participants with vital signs data that meet criteria of potential clinical concern		Day 1 through 61
Primary	Number of participants with ECG data that meet criteria of potential clinical concern		Day 1 through 61
Primary	Number of participants with abnormal clinically significant laboratory measurements		Day 1 through 61
Primary	C-SSRS (suicidality assessment)		Day 1 through 61
Secondary	MDS-UPDRS part III	MDS - Unified Parkinson's Disease Rating Scale Part III	Day 1, Periods 1-3

External Links

•   To obtain contact information for a study center near you, click here.