NCT06421714已完成1 期
A Phase I, Single-Center, Open-Label, Two-Period, Single Sequence, Two Treatment Drug-Drug Interaction Study of GZ/SAR402671 (Venglustat) and Itraconazole in Healthy Male Subjects
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年8月16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
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC) of venglustat
研究概览
简要总结
The purpose of this study is to assess in healthy adult male participants the effects of itraconazole on the pharmacokinetics of venglustat and to assess the safety and tolerability of venglustat with and without coadministration of itraconazole. The maximum duration for participants from screening is between 32 to 62 days.
详细描述
Total study duration for participants is up to 62 days including screening up to 28 days, 1 day of treatment in period 1, washout of 7 days, 13 days of treatment in period 2, and follow up period 10-14 days after last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants, between 18 and 55 years of age, inclusive.
- •Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 30.0 kg/m2, inclusive.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Normal vital signs, electrocardiogram, and laboratory parameters.
- •Having given written informed consent prior to undertaking any study-related procedure.
- •Not under any administrative or legal supervision.
- •Male participant, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (spermicide or intra-uterine device or hormonal contraceptive) from the inclusion up to 4 months after the last dosing.
- •Male participant, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after the last dosing.
- •Male participant has agreed not to donate sperm from the inclusion up to 4 months after the last dosing.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •Blood donation, any volume, within 2 months before inclusion.
- •Symptomatic postural hypotension excluding vasovagal episode associated with a blood draw.
- •Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- •Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled). Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- •Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency Virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- •Positive result on urine drug screen or urine alcohol test.
- •Any contraindications to itraconazole, according to the applicable labeling.
研究组 & 干预措施
Venglustat and Itraconazole
Experimental
The first period will include a single dose administration of venglustat followed by a second period including a multiple dose administration of itraconazole for 12 days and a second single dose administration of venglustat on the 6th day of itraconazole administration
干预措施: Venglustat (Drug)
Venglustat and Itraconazole
Experimental
The first period will include a single dose administration of venglustat followed by a second period including a multiple dose administration of itraconazole for 12 days and a second single dose administration of venglustat on the 6th day of itraconazole administration
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC) of venglustat
时间窗: Multiple time points up to 21 days
Area under the plasma concentration versus time curve calculated from time zero to the real time (tlast) (AUClast) of venglustat
时间窗: Multiple time points up to 21 days
次要结局
- Time to reach Cmax (tmax) of hydroxyitraconazole(Multiple time points up to 21 days)
- Maximum plasma concentration observed (Cmax) of itraconazole(Multiple time points up to 21 days)
- Maximum plasma concentration observed (Cmax) of hydroxyitraconazole(Multiple time points up to 21 days)
- Time to reach Cmax (tmax) of venglustat(Multiple time points up to 21 days)
- Maximum plasma concentration observed (Cmax) of venglustat(Multiple time points up to 21 days)
- Time to reach Cmax (tmax) of itraconazole(Multiple time points up to 21 days)
- Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of itraconazole(Multiple time points up to 21 days)
- Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of venglustat(Multiple time points up to 21 days)
- Terminal half-life (t1/2) of venglustat(Multiple time points up to 21 days)
- Area under the plasma concentration versus time curve calculated over the dosing interval (12 h) (AUC0-12) of itraconazole(Multiple time points up to 21 days)
- Plasma concentration observed just before treatment administration during repeated dosing (Ctrough) of hydroxyitraconazole(Multiple time points up to 21 days)
- Area under the plasma concentration versus time curve over the dosing interval (12 h) (AUC0-12) of hydroxyitraconazole(Multiple time points up to 21 days)
研究者
研究点 (1)
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