An Open-Label, Phase 1 Study to Investigate the Comparability of the Pharmacokinetics of Olomorasib (LY3537982) Between Two Capsule Formulations and to Evaluate the Food Effect in Healthy Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
研究概览
简要总结
The purpose of this study is to compare and see how food affects the amount of olomorasib in the blood when olomorasib is taken in two different capsule forms. Participation in the study will last approximately 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Japanese participants who are overtly healthy as determined by medical evaluation including medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations.
- •Have a body mass index within the range 18.5 to 30.0 kilograms per square meter (kg/m²), inclusive, at screening.
- •Participants assigned male at birth (AMAB) may participate in this study.
排除标准
- •Have a history of malignancy within 5 years prior to screening except for basal cell or squamous epithelial carcinomas of the skin or in situ carcinoma of the cervix that have been resected with no evidence of metastatic disease for 3 years.
- •Have known allergies to olomorasib or any component of the formulation, or related compounds.
- •Use of any other investigational drug or device within 30 days or 5 half-lives (if known), whichever is longer, of the first dose of study drug.
- •Have previously completed or withdrawn from this study or any other study investigating olomorasib and have previously received olomorasib
- •Show evidence of hepatitis B or positive hepatitis B surface antigen.
- •Show evidence of hepatitis C or have a positive hepatitis C virus antibody test.
- •Show evidence of HIV infection or positive HIV antigen or HIV antibodies.
- •Show evidence of syphilis or have a positive syphilis test.
研究组 & 干预措施
Olomorasib Test (Part A)
Olomorasib test formulation administered orally with or without food.
干预措施: Olomorasib (Drug)
Olomorasib Reference (Part B)
Olomorasib reference formulation administered orally with or without food.
干预措施: Olomorasib (Drug)
Olomorasib Test (Part B)
Olomorasib test formulation administered orally with or without food.
干预措施: Olomorasib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olomorasib
时间窗: Day 1 (Predose) through Day 7 (72 Hours Postdose)
PK: Area under the Concentration versus Time Curve from Time Zero to Time t (AUC[0-tlast]) of Olomorasib
时间窗: Day 1 (Predose) through Day 7 (72 Hours Postdose)
次要结局
未报告次要终点