NCT03212313终止1 期
A Two-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Tozadenant
Biotie Therapies Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the pharmacokinetics (PK) [area under the time-concentration curve] of a single-dose of tozadenant in subjects with hepatic impairment to healthy subjects.
研究概览
简要总结
This is a two-part, open label, single-dose study that will evaluate the PK of tozadenant in subjects with different degrees of hepatic impairment to the PK of a single-dose of tozadenant in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must fulfill the following to participate:
- •Subject has given his/her written informed consent on an IEC or IRB approved consent form.
- •Subject understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.
- •Be either male or female 18 years old
- •Have a BMI ≥ 18.5 and ≤ 40.0 kg/m2 at screening
- •Is a continuous non-smoker or a smoker who will consume up to 10 cigarettes/day
- •Child bearing females should be sexually inactive (abstinent) prior to dosing
- •Females subjects of non childbearing potential must have undergone one of the following sterilization or be postmenopausal
- •Subjects with mild, moderate, or severe hepatic impairment must:
- •Have a medical history consistent with a diagnosis of hepatic impairment.
- •Have a diagnosis of chronic (> 6 months), stable hepatic insufficiency
- •Healthy subjects must be:
- •Medically healthy with no significant medical history
排除标准
- •Subjects must not be enrolled in the study if they:
- •Previously participated in any study with tozadenant
- •Has orthostatic hypotension, history or symptoms of cardiovascular disease, or hypertensive crisis.
- •Currently participating in or has participated in another study and received drug (active or placebo)
- •Have a known diagnosis of malignant melanoma
- •Have a current episode of major depression
- •Has a recent history of suicide attempt
- •Has any other condition or clinically significant abnormal findings on the physical or neurological examination, psychiatric and medical history
- •Had surgery or any medical condition within 6 months
- •Unable to refrain from or anticipates the use of any drugs, vitamins, natural or herbal supplements
- •Subject is currently lactating or pregnant or planning to become pregnant.
- •Recent donation of blood, plasma or significant blood loss
- •Has positive test for ethanol or drugs of abuse or a history of chronic alcohol or drug abuse
- •Clinically significant medical history
- •Positive results hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) for Healthy Volunteers only.
研究组 & 干预措施
Healthy Subjects
Active Comparator
Study dose of 120 mg
干预措施: Tozadenant (Drug)
Mild Hepatic Impairment
Experimental
Study dose of 120 mg
干预措施: Tozadenant (Drug)
Moderate Hepatic Impairment
Experimental
Study dose of 120 mg
干预措施: Tozadenant (Drug)
Severe Hepatic Impairment
Experimental
Up to a maximum study dose of 120 mg
干预措施: Tozadenant (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics (PK) [area under the time-concentration curve] of a single-dose of tozadenant in subjects with hepatic impairment to healthy subjects.
时间窗: up to 12 days
To evaluate the pharmacokinetics (PK) \[area under the time-concentration curve\] of a single-dose of tozadenant in subjects with hepatic impairment compared to the PK of a single-dose of tozadenant in healthy subjects.
次要结局
- Subjects with hepatic impairment will be evaluated for safety assessments (adverse events and treatment-related adverse events) by physical examinations.(up to 12 days)
研究者
研究点 (2)
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