To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

Recruitment & Eligibility

Inclusion Criteria

Body mass index of ≥18.0 to 40.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [(110 pounds (lbs)].
Age that is within ±10 years of the median age for the severe renal impairment cohort. Bodyweight that is within ±15 kg of the median bodyweight for the severe renal impairment cohort.
Severe renal function: estimated glomerular filtration rate (eGFR) <30 mL/min (not requiring dialysis) determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Stable disease, defined as no clinically significant changes in disease status as documented by the most recent eGFR assessment (within at least 3 months before Screening).
Stable concomitant medications for the management of individual participants medical history.

Key

Exclusion Criteria

Serious risk of suicide in the opinion of the investigator.
History of substance or alcohol use disorder (excluding nicotine or caffeine) within 12 months prior to signing the informed consent form (ICF).
Receipt of severe acute respiratory syndrome coronavirus 2(SARS-CoV2) vaccine or booster within 7 days of planned dosing.
Have recently been diagnosed with symptomatic Coronavirus Disease 2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the ICF.
Positive drug screen including tetrahydrocannabinol (THC).
Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
Positive drug screen including THC (except with a vail prescription other than medical marijuana).
Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
Participants who require dialysis.
Participant with nephrotic syndrome.
Abnormal hemoglobin.
Abnormal blood pressure measurement or heart rate at Screening or Check-in.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

Arm && Interventions

Group	Intervention	Description
Normal Renal Function	Tavapadon	Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1.
Severe Renal Impairment	Tavapadon	Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon	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	pre-dose and at multiple timepoints post-dose up to Day 7
Maximum Observed Plasma Concentration (Cmax) of Tavapadon	pre-dose and at multiple timepoints post-dose up to Day 7

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score	Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values	Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Laboratory Values	Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results	Day 1 up to Follow-up (Day 15)
Number of Participants with Adverse Events (AEs) and AEs by Severity	Day 1 up to Follow-up (Day 15)
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values	Day 1 up to Follow-up (Day 15)

Recruitment & Eligibility