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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373072
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson Disease Drug: PF-06649751 Drug: Trimethobenzamide Hydrochloride Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. MDS-UPDRS part III [ Time Frame: Day 1, Periods 1-3 ]
    MDS - Unified Parkinson's Disease Rating Scale Part III



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373072


Locations
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United States, California
Collaborative Neuroscience Network, LLC.
Long Beach, California, United States, 90806
United States, Florida
MD Clinical
Hallandale, Florida, United States, 33009
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Maryland
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201
Parkinson's Movement Disorder Center of Maryland
Elkridge, Maryland, United States, 21075
United States, Texas
Neurology Consultants of Dallas, PA
Dallas, Texas, United States, 75231
Walnut Hill Medical Center
Dallas, Texas, United States, 75231
Belgium
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02373072    
Other Study ID Numbers: B7601009
2014-004389-54 ( EudraCT Number )
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: January 2017
Keywords provided by Pfizer:
Pakinson's Disease, Movement Disorders
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Trimethobenzamide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents