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NCT Number: NCT02373072

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics 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.

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Key information

Conditions

Idiopathic Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-06649751

Drug

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

Drug

300mg TID, Capsules. Optional in both Cohorts.

Placebo

Drug

Subjects completing all three treatment periods will be receiving placebo once.

Primary outcomes

  1. Number and proportion of subjects with Adverse Events (AEs)

    Time frame: Day 1 through 61

  2. Number of participants with vital signs data that meet criteria of potential clinical concern

    Time frame: Day 1 through 61

  3. Number of participants with ECG data that meet criteria of potential clinical concern

    Time frame: Day 1 through 61

  4. Number of participants with abnormal clinically significant laboratory measurements

    Time frame: Day 1 through 61

  5. C-SSRS (suicidality assessment)

    Time frame: Day 1 through 61

Secondary outcomes

  1. MDS-UPDRS part III

    Time frame: Day 1, Periods 1-3

    MDS - Unified Parkinson's Disease Rating Scale Part III

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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