NCT05283915已完成1 期
An Open-label Phase 1, Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Dose in Adult Participants With Mild Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of PK parameters Tolebrutinib: AUC
研究概览
简要总结
The purpose of this parallel group, Phase 1, open-label, 2-arm, single dose, multi-center study is to assess the effect of mild hepatic impairment on pharmacokinetics (PK), safety and tolerability of tolebrutinib compared with normal hepatic function, in male and female participants aged 18 to 79 years.
详细描述
The total duration of the study per participant is up to 41 days including:
- A screening period of up to 4 weeks (Days -28 to -2)
- A 5-day, open-label treatment period
- Up to 7 days post-treatment follow-up period
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For participants with mild hepatic impairment
- •Stable chronic liver disease assessed by medical history, physical examination, and laboratory values
- •Child-Pugh total score ranging from 5 to 6, inclusive.
- •Laboratory parameters within the acceptable range for participants with hepatic impairment; however, estimated glomerular filtration rate (eGFR) should be above or equal to 60 mL/min
- •For all participants
- •Body weight between 50.0 and 115.0 kg, inclusive, if male, between 40.0 and 100 kg, inclusive, if female, and body mass index (BMI) within the range 18 to 40 kg/m2, inclusive, at screening.
- •Participant with platelet count ≥150 000/μL at the screening visit and at Day -1
排除标准
- •For all participants :
- •Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from supine to standing position at screening and Day -1
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •History of drug or alcohol abuse within 1 year before inclusion.
- •Smoking regularly more than 15 cigarettes or equivalent per day, unable to refrain from smoking over 8 cigarettes per day during the institutionalization.
- •Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
- •Use of any herbal medicines 2 weeks before IMP administration
- •Treatment with a strong or moderate CYP3A inhibitors, a strong, moderate or mild CYP2C8 inhibitors OR CYP3A, CYP2C8 inducers within 14 days before the study treatment administration or 5 half-lives, whichever is longer
- •Specific for participants with mild hepatic impairment:
- •Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic, renal, infectious disease, moderate or severe hepatic impairment (Child-Pugh total score greater than or equal to 7), or signs of acute illness.
- •Hepatocarcinoma.
- •Acute liver disease.
- •Hepatic encephalopathy Grade 2, 3, and
- •Esophageal bleeding which is caused by esophageal varices within 3 months before inclusion.
- •NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
研究组 & 干预措施
Mild hepatic impairment group
Experimental
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
干预措施: tolebrutinib (Drug)
Normal hepatic function group
Experimental
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
干预措施: tolebrutinib (Drug)
结局指标
主要结局
Assessment of PK parameters Tolebrutinib: AUC
时间窗: From Day 1 to Day 4
Area under the plasma concentration (AUC) versus time curve extrapolated to infinity
Assessment of PK parameters M2: AUC
时间窗: From Day 1 to Day 4
次要结局
- Assessment of PK parameters Tolebrutinib: AUClast(From Day 1 to Day 4)
- Assessment of PK parameters M2: AUClast(From Day 1 to Day 4)
- Assessment of PK parameters Tolebrutinib: Cmax(From Day 1 to Day 4)
- Assessment of PK parameters M2: Cmax(From Day 1 to Day 4)
- Number of participants with treatment-emergent adverse events (TEAEs)(From Day 1 to Day 8)
研究者
研究点 (2)
Loading locations...
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