NCT04752540已完成1 期
A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
研究概览
简要总结
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
- •Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive
- •Subjects with mild hepatic impairment will have grade A Child-Pugh score of 5 to 6 at screening and Day -1:
- •Subjects with moderate hepatic impairment: will have grade B Child-Pugh score of 7 to 9 at screening and Day -1
- •Subjects with normal liver function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
- •Subjects with normal liver function are matched by gender, age (±10 years) and BMI (± 20%) to at least one hepatically impaired subject.
排除标准
- •Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
- •Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
- •Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
- •Subjects with a history of or any concomitant active malignancy.
- •Subjects with a history of drug or alcohol abuse.
- •Subjects with, or with a history of, any clinically significant neurological, renal, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
- •Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
- •Hepatically impaired subjects with liver transplantation, autoimmune liver disease, or drug-induced liver damage
研究组 & 干预措施
Mild hepatic impairment
Experimental
120 mg olorofim
干预措施: Olorofim (Drug)
Moderate hepatic impairment
Experimental
60 to 120 mg olorofim
干预措施: Olorofim (Drug)
Normal hepatic function
Active Comparator
120 mg olorofim
干预措施: Olorofim (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
时间窗: 0-96 hours
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0-96 hours
次要结局
- Apparent Elimination Half Life (t1/2)(0-96 hours)
- Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)(0-96 hours)
- Number of Participants With Treatment-Emergent Adverse Events(10 days)
- Time to Reach Maximum Plasma Concentration (Tmax)(0-96 hours)
研究者
研究点 (2)
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