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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2023 |
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Main ID: |
NCT02373072 |
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Date of registration:
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20/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02373072 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Belgium
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Parkinson Disease
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Intervention(s)
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Drug: PF-06649751
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Drug: Placebo
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Drug: Trimethobenzamide Hydrochloride
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Primary Outcome(s)
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Number and proportion of subjects with Adverse Events (AEs)
[Time Frame: Day 1 through 61]
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C-SSRS (suicidality assessment)
[Time Frame: Day 1 through 61]
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Number of participants with ECG data that meet criteria of potential clinical concern
[Time Frame: Day 1 through 61]
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Number of participants with vital signs data that meet criteria of potential clinical concern
[Time Frame: Day 1 through 61]
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Number of participants with abnormal clinically significant laboratory measurements
[Time Frame: Day 1 through 61]
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Secondary Outcome(s)
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MDS-UPDRS part III
[Time Frame: Day 1, Periods 1-3]
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Secondary ID(s)
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B7601009
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2014-004389-54
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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