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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Oral tablets
Los Alamitos, California
Los Alamitos, California, United States
Hollywood, Florida
Hollywood, Florida, United States
Orlando, Florida
Orlando, Florida, United States
South Miami, Florida
South Miami, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Minimum Steady-state Plasma Concentration (Cmin,ss) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Trough Concentration (Ctrough) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Time of Maximum Observed Concentration (Tmax) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Degree of Fluctuation [(Cmax - Cmin)/Cavg,ss] of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Peak-to-Trough Ratio (PTR) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Swing [(Cmax - Cmin)/Cmin,ss] of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Apparent Clearance of Tavapadon From Plasma (CL/F)
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Decatur, Georgia
Decatur, Georgia, United States
Farmington Hills, Michigan
Farmington Hills, Michigan, United States
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 28
Number of Participants With Adverse Events (AEs) and AEs by Severity
Time frame: Up to Day 36
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 29
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time frame: Up to Day 29
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Up to Day 29
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: 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.
Time frame: Up to Day 29