Effects of CYP3A4 Inhibition by Itraconazole on the Pharmacokinetics of LY3200882 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
研究概览
简要总结
The main purpose of this study is to evaluate the effect of itraconazole on the amount of LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will occur up to 28 days prior to enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or postmenopausal females, as determined by medical history and physical examination
排除标准
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Have used or intend to use over-the-counter or prescription medication including herbal medications within 14 days prior to dosing and during the study (with the exception of vitamins and occasional acetaminophen or ibuprofen, which will be permitted at the discretion of the investigator). Drugs that are known substrates, inducers, or inhibitors of CYP3A4 are specifically excluded within 30 days of dosing and throughout the study
研究组 & 干预措施
LY3200882
LY3200882 administered orally.
干预措施: LY3200882 (Drug)
Itraconazole + LY3200882
Itraconazole + LY3200882 administered orally.
干预措施: LY3200882 (Drug)
Itraconazole + LY3200882
Itraconazole + LY3200882 administered orally.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3200882
时间窗: Baseline through 72 hours post-dose
PK: Cmax of LY3200882
PK: Area Under the Concentration Curve (AUC) of LY3200882
时间窗: Baseline through 72 hours post-dose
PK: AUC of LY3200882
次要结局
未报告次要终点