A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following Single Dose of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Tavapadon
研究概览
简要总结
The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of ≥17.5 to 42.0 0 kilograms per meter square (kg/m^2), inclusive, and a total body weight >50 kilograms (kg) [110 pounds (lbs)].
- •Must meet the criteria for Class A or B of the modified Child-Pugh classification.
- •Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
- •Previous alcohol abuse is permitted provided that the participant is willing and able to follow lifestyle guidelines and has a negative breath alcohol test at Screening and Check-in (Day -1).
排除标准
- •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 informed consent form (ICF).
- •Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- •Has received study drug in a clinical trial of Tavapadon within 12 months of signing the ICF.
- •Acute hepatitis.
- •Grade ≥2 hepatic encephalopathy.
- •Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
- •Primary biliary cholangitis or primary sclerosing cholangitis.
- •Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Moderate Hepatic Function
Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.
干预措施: Tavapadon (Drug)
Mild Hepatic Function
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
干预措施: Tavapadon (Drug)
Normal Hepatic Function
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
干预措施: Tavapadon (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
时间窗: pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon
时间窗: 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
时间窗: pre-dose and at multiple timepoints post-dose up to Day 7
次要结局
- 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))