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

September 20, 2023 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network, LLC.
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center, Inc.
      • Elkridge, Maryland, United States, 21075
        • Parkinson's Movement Disorder Center of Maryland
    • Texas
      • Dallas, Texas, United States, 75231
        • Neurology Consultants of Dallas, PA
      • Dallas, Texas, United States, 75231
        • Walnut Hill Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
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.
Drug: Trimethobenzamide Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
Drug: Placebo
Subjects completing all three treatment periods will be receiving placebo once.
Experimental: Cohort 2
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
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.
Drug: Trimethobenzamide Hydrochloride
300mg TID, Capsules. Optional in both Cohorts.
Drug: Placebo
Subjects completing all three treatment periods will be receiving placebo once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of subjects with Adverse Events (AEs)
Time Frame: Day 1 through 61
Day 1 through 61
Number of participants with vital signs data that meet criteria of potential clinical concern
Time Frame: Day 1 through 61
Day 1 through 61
Number of participants with ECG data that meet criteria of potential clinical concern
Time Frame: Day 1 through 61
Day 1 through 61
Number of participants with abnormal clinically significant laboratory measurements
Time Frame: Day 1 through 61
Day 1 through 61
C-SSRS (suicidality assessment)
Time Frame: Day 1 through 61
Day 1 through 61

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS part III
Time Frame: Day 1, Periods 1-3
MDS - Unified Parkinson's Disease Rating Scale Part III
Day 1, Periods 1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimated)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7601009
  • 2014-004389-54 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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