NCT05126329终止1 期
An Open-label Pharmacokinetic and Tolerability Study of Amcenestrant Given as a Single Dose in Female Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- PK assessment: Area under the plasma concentration (AUC)
研究概览
简要总结
This is a Phase 1, parallel, open-label, 3-arm study to investigate the pharmacokinetic (PK) parameters of amcenestrant in female participants aged 40 to 75 years with mild and moderate hepatic impairment, and in matched participants with normal hepatic function.
详细描述
The total study duration from screening period is approximately 41 days.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For participants with hepatic impairment:
- •Participant must be 40 to 75 years of age, inclusive.
- •Female participants who are postmenopausal or are post-bilateral surgical oophorectomy not linked to a history of cancer. Menopause is defined as being amenorrheic for at least 12 months without an alternative medical cause, with plasma FSH level >30 IU/L or age ≥60 years.
- •Stable chronic liver disease assessed by medical history, physical examination, laboratory values
- •Body weight within the range 50 kg (40 kg for site in South Korea) to 110 kg and body mass index (BMI) within the range 18 to 36 kg/m2, inclusive.
- •For moderate hepatic impairment cohort: Child-Pugh total score ranging from 7 to 9, inclusive.
- •For mild hepatic impairment cohort: Child-Pugh total score ranging from 5 to 6, inclusive
- •For matched subjects:
- •Participant must be 40 to 75 years of age, inclusive.
- •Female participants who are postmenopausal or are post-bilateral surgical oophorectomy not linked to a history of cancer. Menopause is defined as being amenorrheic for at least 12 months without an alternative medical cause, with plasma FSH level >30 IU/L or age ≥60 years.
- •Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- •Body weight within the range 50 kg (40 kg for site in South Korea) to 100 kg and body mass index (BMI) within the range 18 to 36 kg/m2, inclusive.
排除标准
- •For participants with hepatic impairment:
- •History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) 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 (Smoking is not allowed within 8 hours after amcenestrant administration).
- •Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
- •Non-live vaccines including Covid-19: last administration of a vaccine within 1 week (symptoms-free) to 2 weeks before inclusion.
- •Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
- •Use of any herbal medicines 1 week before IMP administration and up to the end of PK sampling following the IMP administration
- •Live-vaccines: last administration of a vaccine within 4 weeks before inclusion
- •Treatment with a strong CYP3A, CYP2C8 or any UGTs inhibitor within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- •Treatment with a strong or moderate CYP3A, CYP2C8 or any UGTs inducer within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- •Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic, renal, infectious disease, severe hepatic impairment (Child-Pugh total score greater than or equal to 10), or signs of acute illness, hepatocarcinoma, acute hepatitis, Hepatic encephalopathy Grade 2, 3, and 4
- •Esophageal bleeding, which is caused by esophageal varices, within 3 months before inclusion
- •For matched subjects:
- •History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) 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 (Smoking is not allowed within 8 hours after amcenestrant administration).
- •Excessive consumption of beverages containing xanthine bases (more than 5 cups or glasses per day).
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic, or infectious disease, or signs of acute illness, unless the Investigator considers an abnormality to be not clinically significant.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month.
- •Non-live vaccines including Covid-19: last administration of a vaccine within 1 week (symptoms-free) to 2 weeks before inclusion
- •Live-vaccines: last administration of a vaccine within 4 weeks before inclusion
- •Treatment with a strong CYP3A, CYP2C8 or any UGTs inhibitor within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- •Treatment with a strong or moderate CYP3A, CYP2C8 or any UGTs inducer within 14 days before first study treatment administration or 5 half-lives whichever is longer.
- •Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 72 hours before inclusion.
- •Use of any herbal medicines 1 week before IMP administration and up to the end of PK sampling following the IMP administration 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
Participants with mild hepatic impairment
Experimental
Amcenestrant 200 mg single dose on Day 1 in fed condition
干预措施: amcenestrant (Drug)
Participants with moderate hepatic impairment
Experimental
Amcenestrant 200 mg single dose on Day 1 in fed condition
干预措施: amcenestrant (Drug)
Participants with normal hepatic function
Experimental
Amcenestrant 200 mg single dose on Day 1 in fed condition
干预措施: amcenestrant (Drug)
结局指标
主要结局
PK assessment: Area under the plasma concentration (AUC)
时间窗: From Day 1 to Day 5
Area under the plasma concentration versus time curve of amcenestrant
Pharmacokinetic (PK) assessment: Maximum plasma concentration observed (Cmax)
时间窗: From Day 1 to Day 5
Maximum plasma concentration observed (Cmax) of amcenestrant
次要结局
- PK assessment: AUCu of amcenestrant(From Day 1 to Day 5)
- Number of participants with adverse events (AEs) / treatment-emergent adverse events (TEAEs)(From the date when the ICF is signed to the end of study (approximately Day 10))
- PK assessment: AUC of M7(From Day 1 to Day 5)
- PK assessment: Tmax of amcenestrant(From Day 1 to Day 5)
- PK assessment: Area under the plasma concentration versus time curve (AUClast) of amcenestrant(From Day 1 to Day 5)
- PK assessment: AUClast of M7(From Day 1 to Day 5)
- PK assessment: Maximum unbound plasma concentration (Cmax u) of amcenestrant(From Day 1 to Day 5)
- PK assessment: Cmax of M7(From Day 1 to Day 5)
研究者
研究点 (3)
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