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

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NCT02373072

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Study Location
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
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Contact
1-800-718-1021
[email protected]
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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

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Idiopathic Parkinson DiseaseA Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
NCT02373072
  1. Long Beach, California
  2. Hallandale, Florida
  3. Atlanta, Georgia
  4. Baltimore, Maryland
  5. Elkridge, Maryland
  6. Dallas, Texas
  7. Dallas, Texas
  8. Brussels,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Idiopathic Parkinson Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase 1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist PF-06649751 is Safe and Well Tolerated. Neurol Ther. 2018 Dec;7(2):307-319. doi: 10.1007/s40120-018-0114-z. Epub 2018 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)		18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373072
Other Study ID Numbers  ICMJE B7601009
2014-004389-54 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP