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

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NCT02373072

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Parkinson Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History of troublesome dyskinesias

- History of surgical intervention for Parkinson's disease

NCT02373072
Pfizer
Completed
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease

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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Idiopathic Parkinson Disease
  • 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 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.
    Interventions:
    • Drug: PF-06649751
    • Drug: Trimethobenzamide Hydrochloride
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: PF-06649751
    • Drug: Trimethobenzamide Hydrochloride
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2016
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States
 
 
NCT02373072
B7601009
2014-004389-54 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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