A Single Dose Study to Investigate the Pharmacokinetics of Ridaforolimus in Patients With Hepatic Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
研究概览
简要总结
This study will evaluate the pharmacokinetics of ridaforolimus including the area under the concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after administration of a single dose of ridaforolimus in patients with moderate hepatic insufficiency and healthy matched control subjects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hepatic Patients:
- •Female patient is of non-child bearing potential
- •Apart from hepatic insufficiency with features of cirrhosis, patient is otherwise in good health
- •Patient has a diagnosis of chronic stable hepatic insufficiency with features of cirrhosis
- •Healthy Subjects:
- •Female subject is of non-childbearing potential
- •Subject is in good health
排除标准
- •Hepatic Patients and Healthy Subjects:
- •Works a night shift and is not able to avoid night shift work during the study
- •Has a history of stroke, seizure or major neurological disease
- •Has a history of cancer
- •Is unable to refrain from or anticipates the use of any prescription or non-prescription drugs during the study
- •Consumes excessive amounts of alcohol or caffeine
- •Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
研究组 & 干预措施
Patients with Moderate Hepatic Insufficiency
Patients with moderate hepatic insufficiency (a score of 7 to 9 on the Child-Pugh's scale) received a single 10 mg dose of ridaforolimus.
干预措施: ridaforolimus (Drug)
Healthy Control Subjects
Healthy control subjects were matched by race, age, gender, and body mass index (BMI) to the patients with moderate hepatic insufficiency. The healthy control subjects also received a single 10 mg dose of ridaforolimus.
干预措施: ridaforolimus (Drug)
结局指标
主要结局
Area Under the Curve (AUC[0-infinity]) of ridaforolimus following a single oral dose.
时间窗: 288 hours postdose
Apparent Terminal Half-life (t1/2) of a Single Oral Dose of Ridaforolimus.
时间窗: 288 hours postdose
Maximum Concentration (Cmax) of ridaforolimus following a single oral dose.
时间窗: 288 hours postdose
Tmax of a Single Oral Dose of Ridaforolimus.
时间窗: 288 hours postdose
次要结局
未报告次要终点