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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004389-54 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 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. |
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| Cohort 2 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of subjects with Adverse Events (AEs) | Day 1 through 61 | |
| Number of participants with vital signs data that meet criteria of potential clinical concern | Day 1 through 61 | |
| Number of participants with ECG data that meet criteria of potential clinical concern | Day 1 through 61 | |
| Number of participants with abnormal clinically significant laboratory measurements | Day 1 through 61 | |
| C-SSRS (suicidality assessment) | Day 1 through 61 |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS part III | MDS - Unified Parkinson's Disease Rating Scale Part III | Day 1, Periods 1-3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, LLC. | Long Beach | California | 90806 | United States | ||
| MD Clinical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30361858 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Trimethobenzamide Hydrochloride | Drug | 300mg TID, Capsules. Optional in both Cohorts. |
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| Placebo | Drug | Subjects completing all three treatment periods will be receiving placebo once. |
|
| Hallandale |
| Florida |
| 33009 |
| United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | United States |
| Parkinson's Movement Disorder Center of Maryland | Elkridge | Maryland | 21075 | United States |
| Neurology Consultants of Dallas, PA | Dallas | Texas | 75231 | United States |
| Walnut Hill Medical Center | Dallas | Texas | 75231 | United States |
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C100146 | trimethobenzamide |
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