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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following Single Dose of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: Tavapadon


Participation Criteria
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Eligibility Criteria
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Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe Renal Impairment<br>Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: CVL-751;|
| Experimental: Normal Renal Function<br>Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, on Day 1. | Drug: Tavapadon<br>* Oral tablets<br>* Other names: CVL-751;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Electrocardiogram (ECG) Values |  | 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) | 
| 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 Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score |  | Day 1 up to Follow-up (Day 15) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, Severe Renal Impairment