A Phase 1, Open-label Study to Assess the Effect of Food on the Pharmacokinetics of Tersolisib Administered Under Fasted Conditions, With a High-fat Meal, and With a Low-fat Meal, in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
研究概览
简要总结
The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations.
- •Normal blood pressure and pulse rate.
- •Body mass index (BMI) within the range 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive.
- •Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
排除标准
- •History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
- •Metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- •Biliary disease, including cholecystectomy
- •Gastrointestinal (GI) disease
- •Hematological disease
- •Neurological disease
- •Significant history of, or presence of liver disease, including abnormal liver function tests above 1.25 times the upper limit of normal range per the laboratory's reference ranges at screening or admission, or
- •Clinically significant, active cardiovascular disease or history of myocardial infarction or significant cardiovascular disease.
- •History of a major surgical procedure within 30 days prior to screening.
- •Known allergies to tersolisib or related compounds.
研究组 & 干预措施
Group 2 Treatment A Fasted
Tersolisib administered orally.
干预措施: Tersolisib (Drug)
Group 2 Treatment C Low-Fat Meal
Tersolisib administered orally.
干预措施: Tersolisib (Drug)
Group 2 Treatment C Low-Fat Meal
Tersolisib administered orally.
干预措施: Low-fat Meal (Other)
Group 1 Treatment A Fasted
Tersolisib administered orally.
干预措施: Tersolisib (Drug)
Group 1 Treatment B High-Fat Meal
Tersolisib administered orally.
干预措施: High-fat Meal (Other)
Group 1 Treatment B High-Fat Meal
Tersolisib administered orally.
干预措施: Tersolisib (Drug)