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The primary purpose of the study is to evaluate the bioequivalence (BE) of tavapadon 15 milligram (mg) tablet to 3x5 mg tablets in participants with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg | Experimental | Participants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21. Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28. |
|
| Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg | Experimental | Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21. Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 | |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCÏ„) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 | |
| Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol-defined inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Alamitos, California | Los Alamitos | California | 90720 | United States | ||
| Hollywood, Florida |
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| Trough Concentration (Ctrough) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Time of Maximum Observed Concentration (Tmax) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Peak-to-Trough Ratio (PTR) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Apparent Clearance of Tavapadon From Plasma (CL/F) | Pre-dose and at multiple timepoints post-dose up to Day 28 |
| Number of Participants With Adverse Events (AEs) and AEs by Severity | Up to Day 36 |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Vital Sign Values | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Up to Day 29 |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Up to Day 29 |
| Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Up to Day 29 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Orlando, Florida | Orlando | Florida | 32806 | United States |
| South Miami, Florida | South Miami | Florida | 33143 | United States |
| Decatur, Georgia | Decatur | Georgia | 30030 | United States |
| Farmington Hills, Michigan | Farmington Hills | Michigan | 48334 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D000080874 | Synucleinopathies |
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