A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild, Moderate, or Severe Hepatic Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
研究概览
简要总结
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational study drug NBI-98854 in subjects with normal hepatic function or mild, moderate, or severe hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Male or female, 18 to 75 years of age.
- •Healthy volunteers must be in good general health.
- •Subjects with hepatic impairment must be judged to be in stable condition.
- •Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study.
- •Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeeding.
- •Have a body mass index (BMI) of 18 to 40 kg/m2 (both inclusive).
排除标准
- •Report more than two alcoholic beverages daily or more than 14 alcoholic beverages weekly withing 7 days of study start.
- •Have a known history of neuroleptic malignant syndrome.
- •Have a positive human immunodeficiency virus (HIV) antibody result at screening or have a history of positive result.
- •Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- •Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- •Had a blood loss greater than or equal to 500 mL or donated blood within 56 days of study start.
- •Have had previous exposure with NBI-98854.
研究组 & 干预措施
Healthy Volunteers
single dose of NBI-98854 50 mg capsule
干预措施: NBI-98854 50 mg capsule (Drug)
Mild Hepatic Impairment
single dose of NBI-98854 50 mg capsule
干预措施: NBI-98854 50 mg capsule (Drug)
Moderate Hepatic Impairment
single dose of NBI-98854 50 mg capsule
干预措施: NBI-98854 50 mg capsule (Drug)
Severe Hepatic Impairment
single dose of NBI-98854 50 mg capsule
干预措施: NBI-98854 50 mg capsule (Drug)
结局指标
主要结局
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854
时间窗: 45 minutes prior to NBI-98854 dosing, and 15, 30, 45 minutes, and 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose
Number of Participants with Adverse Events following dosing with NBI-98854
时间窗: Up to 36 days
次要结局
未报告次要终点