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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 2016

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • MDS-UPDRS part III
    • Time Frame: Day 1, Periods 1-3
    • MDS – Unified Parkinson’s Disease Rating Scale Part III

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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