NCT05282030已完成1 期
An Open-label, Multi-center Phase 1 Pharmacokinetic and Tolerability Study of Tolebrutinib Given as a Single Oral Dose in Participants With Renal Impairment and in Matched Participants With Normal Renal 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
- 22
- 试验地点
- 4
- 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 study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal renal function, in male and female participants aged 18 to 79 years.
详细描述
The total duration of the study per participant will be up to 38 days including:
- A screening period of up to 4 weeks.
- 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
- 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For participants with severe RI (Part A): Absolute GFR <30 mL/min, and not requiring dialysis (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
- •For participants with moderate RI (Part B conditional): 30 mL/min ≤ absolute GFR ≤59 mL/min (based on estimated glomerular filtration rate [eGFR] by absolute GFR from the MDRD formula with individual body surface area (BSA), without race correction), with a variability within +/- 20% between screening and Day -1 assessments
- •For participants with normal renal function: Absolute GFR ≥ 90 mL/min (based on eGFR by absolute GFR from the MDRD formula with individual BSA, without race correction), with a variability within +/- 20% between screening and Day -1 assessments.
- •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) between 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 SBP≥30 mmHg within 3 minutes when changing from a supine to a standing position at screening and Day -1
- •Blood donation (usually approximately 500 mL), within 2 months before inclusion.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •History of alcohol or drug abuse within 1 year prior to screening
- •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, moderate or mild CYP2C8 inducer or inhibitor, OR a strong, moderate or mild CYP3A inducer, OR a strong, or moderate CYP3A inhibitor, within 14 days before the study treatment administration or 5 half-lives, whichever is longer
- •Specific criteria for participants with RI
- •Active liver disease, cirrhosis, chronic liver disease, hepatic insufficiency
- •Acute renal failure (de novo or superimposed to preexisting chronic RI), nephrotic syndrome.
- •History of or current hematuria of urologic origin that limits the participant's participation in the study
- •Participant requiring dialysis during the study
- •Specific criteria for participants with normal renal function:
- •Any history or presence of clinically relevant hepatic or renal disease
- •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
Severe Renal Impairment (RI) group (Part A only)
Experimental
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
干预措施: tolebrutinib (Drug)
Normal Renal Function group (Part A and B)
Experimental
Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition
干预措施: tolebrutinib (Drug)
Moderate RI group (Part B only conditional)
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: Cmax(From Day 1 to Day 4)
- Assessment of PK parameters M2: AUClast(From Day 1 to Day 4)
- Assessment of PK parameters Tolebrutinib: AUClast(From Day 1 to Day 4)
- Number of participants with treatment-emergent adverse events (TEAEs)(From Day 1 to Day 8)
- Assessment of PK parameters M2: Cmax(From Day 1 to Day 4)
研究者
研究点 (4)
Loading locations...
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