The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Oral tablets
Jacksonville, Florida
Jacksonville, Florida, United States
Miami, Florida
Miami, Florida, United States
Tampa, Florida
Tampa, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Time frame: pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Time t (AUC0-t) of Tavapadon
Time frame: pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Time frame: pre-dose and at multiple timepoints post-dose up to Day 7
Number of Participants with Adverse Events (AEs) and AEs by Severity
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Time frame: Day 1 up to Follow-up (Day 15)
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Day 1 up to Follow-up (Day 15)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.