A Phase 1 Study to Evaluate the Effects of Multiple Doses of Itraconazole or Carbamazepine on the Single-Dose Pharmacokinetics of LY3537982 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK: Cmax of LY3537982 administered with or without carbamazepine
研究概览
简要总结
The main purpose of this study is to evaluate the effect of itraconazole and carbamazepine on LY3537982 when administered as multiple doses by conducting the blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in adult healthy participants. The study will also evaluate the safety and tolerability of LY3537982. The study is conducted in two parts. Participants will stay in the research center during the study, which will last about 11 and 15 days for part 1 and part 2, respectively, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- •Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
排除标准
- •Females who are lactating or of childbearing potential
- •Clinically significant history of any drug sensitivity, drug allergy, or food allergy
研究组 & 干预措施
LY3537982 + Itraconazole (Part 1)
LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.
干预措施: LY3537982 (Drug)
LY3537982 + Itraconazole (Part 1)
LY3537982 administered orally alone followed by LY3537982 administered in combination with itraconazole orally.
干预措施: Itraconazole (Drug)
LY3537982 + Carbamazepine (Part 2)
LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.
干预措施: LY3537982 (Drug)
LY3537982 + Carbamazepine (Part 2)
LY3537982 administered orally alone followed by LY3537982 administered in combination with carbamazepine orally.
干预措施: Carbamazepine (Drug)
结局指标
主要结局
PK: Cmax of LY3537982 administered with or without carbamazepine
时间窗: Predose on day 1 up to 72 hours postdose on day 13
PK: Cmax of LY3537982 administered with or without carbamazepine
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3537982 administered with or without itraconazole
时间窗: Predose on day 1 up to 72 hours postdose on day 9
PK: Cmax of LY3537982 administered with or without itraconazole
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) of LY3537982 administered with or without itraconazole
时间窗: Predose on day 1 up to 72 hours postdose on day 9
PK: AUC\[0-inf\] of LY3537982 administered with or without itraconazole
PK: AUC[0-inf] of LY3537982 administered with or without carbamazepine
时间窗: Predose on day 1 up to 72 hours postdose on day 13
PK: AUC\[0-inf\] of LY3537982 administered with or without carbamazepine
PK: AUClast of LY3537982 administered with or without carbamazepine
时间窗: Predose on day 1 up to 72 hours postdose on day 13
PK: AUClast of LY3537982 administered with or without carbamazepine
PK: AUC from Time 0 to time of the last measurable concentration (AUClast) of LY3537982 administered with or without itraconazole
时间窗: Predose on day 1 up to 72 hours postdose on day 9
PK: AUClast of LY3537982 administered with or without itraconazole
次要结局
未报告次要终点