The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Oral tablets
Extended-release oral tablets
Madison, Wisconsin
Madison, Wisconsin, United States
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 31
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 31
Number of Participants With Adverse Events (AEs) and AEs by Severity
Time frame: Day 1 up to Day 36
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 31
Number of Participants with Clinically Significant Changes in Vital Sign Values
Time frame: Up to Day 31
Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Up to Day 30
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 31
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 31
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