A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
研究概览
简要总结
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
详细描述
BGB-43395 is a drug that blocks a protein called cyclin-dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division and can drive uncontrolled tumor cell growth. BGB-43395 is being developed for the treatment of patients with advanced solid tumors.
The purpose of this study is to test whether BGB-43395 has any significant drug interactions with midazolam, celecoxib, dabigatran, and rosuvastatin. The main goal of the study is to test whether BGB-43395 affects how other drugs are processed by the body.
This study consists of 2 parts. In Part 1, healthy participants will receive midazolam and celecoxib alone and with BGB-43395. In Part 2, healthy participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
The study will enroll approximately 24 healthy adult participants. The overall time to participate in this study is up to 7 weeks. Blood samples will be taken at specific time points, as well as vital signs and electrocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •Body mass index between 18.0 and 32.0 kg/m^2, inclusive.
- •In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram and vital signs measurements, and clinical laboratory assessments.
- •Participants must not be pregnant or lactating and must agree to use contraception.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute.
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part 1
Participants will receive midazolam and celecoxib alone and with BGB-43395.
干预措施: BGB-43395 (Drug)
Part 1
Participants will receive midazolam and celecoxib alone and with BGB-43395.
干预措施: Midazolam (Drug)
Part 1
Participants will receive midazolam and celecoxib alone and with BGB-43395.
干预措施: Celecoxib (Drug)
Part 2
Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
干预措施: BGB-43395 (Drug)
Part 2
Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
干预措施: Dabigatran etexilate (Drug)
Part 2
Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
时间窗: Samples will be collected predose and at specified timepoints, up to 10 days
AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.
Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast)
时间窗: Samples will be collected predose and at specified timepoints, up to 10 days
AUC0-tlast for midazolam, celecoxib, dabigatran, and rosuvastatin.
Maximum Observed Concentration (Cmax)
时间窗: Samples will be collected predose and at specified timepoints, up to 10 days
Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
Time to Reach Maximum Observed Concentration (Tmax)
时间窗: Samples will be collected predose and at specified timepoints, up to 10 days
Tmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
次要结局
- Number of Participants With Adverse Events (AEs)(From first dose up to 17 days)