To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon... | NCT05404542

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Name	Type	Description	Arm Group Labels	Other Names
Tavapadon	Drug	Oral tablets	Normal Renal Function Severe Renal Impairment

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Jacksonville, Florida		Jacksonville	Florida	32216	United States
Miami, Florida

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases