Pharmacokinetics of Imlunestrant in Participants With Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
研究概览
简要总结
The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female participants with normal liver function. The side effects and tolerability of Imlunestrant will also be evaluated. The study may last up to 46 days for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal
- •Are between the body mass index (BMI) of 18.0 and 42.0 kilograms per meter squared (kg/m²), inclusive, at screening
- •Healthy Participants:
- •- Healthy females as determined by medical history, physical examination, and other screening procedures, with normal liver function
- •Participants with Impaired Liver Function:
- •Females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring
- •Have diagnosis of chronic hepatic impairment (>6 months), with no clinically significant changes within 90 days prior to study drug administration.
排除标准
- •Women of childbearing potential are excluded from the study.
- •Have known allergies to imlunestrant or related compounds
- •Have a history of alcoholism or drug/chemical abuse within 2 years prior to check-in
- •Have received blood products within 2 months prior to check-in
- •Have evidence of HIV infection and/or positive human HIV antibodies
- •Have used or intend to use medications that are strong inhibiters or inducers of cytochrome P450 (CYP)3A4
- •Who smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e-cigarettes (nicotine and non-nicotine) per day.
- •Have a history or presence of cardiovascular (eg, symptomatic bradycardia with resting heart rate of <60 beats per minute), respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
研究组 & 干预措施
Imlunestrant (Normal Hepatic Function)
Participants received a single dose of Imlunestrant 400 milligrams (mg) administered orally on Day 1 in fasted state.
干预措施: Imlunestrant (Drug)
Imlunestrant (Mild Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
干预措施: Imlunestrant (Drug)
Imlunestrant (Moderate Hepatic Impairment)
Participants received a single dose of Imlunestrant 400 mg administered orally on Day 1 in fasted state.
干预措施: Imlunestrant (Drug)
Imlunestrant (Severe Hepatic Impairment)
Participants received a single dose of Imlunestrant 200 mg administered orally on Day 1 in fasted state.
干预措施: Imlunestrant (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Imlunestrant
时间窗: Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)
PK: Cmax of Imlunestrant is reported.
PK: Area Under the Concentration-time Curve From 0 to the Last Measurable Concentration (AUC[0-t]) of Imlunestrant
时间窗: Day 1 (Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post dose)
AUC(0-t) of Imlunestrant is reported.
次要结局
未报告次要终点