A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin
研究概览
简要总结
This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of non-childbearing potential
- •Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
- •Poor peripheral venous access
研究组 & 干预措施
Treatment A
Participants will receive a single oral dose of Digoxin and Rosuvastatin drug cocktail.
干预措施: Digoxin (Drug)
Treatment A
Participants will receive a single oral dose of Digoxin and Rosuvastatin drug cocktail.
干预措施: Rosuvastatin (Drug)
Treatment B
Participants will receive a single dose of Digoxin and Rosuvastatin drug cocktail administered 2 hours after the Divarasib dose on Day 5.
干预措施: Digoxin (Drug)
Treatment B
Participants will receive a single dose of Digoxin and Rosuvastatin drug cocktail administered 2 hours after the Divarasib dose on Day 5.
干预措施: Divarasib (Drug)
Treatment B
Participants will receive a single dose of Digoxin and Rosuvastatin drug cocktail administered 2 hours after the Divarasib dose on Day 5.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin
时间窗: Day 1 of Period 1 and Day 5 of Period 2
Area Under the Plasma Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Digoxin and Rosuvastatin
时间窗: Day 1 of Period 1 and Day 5 of Period 2
Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin
时间窗: Day 1 of Period 1 and Day 5 of Period 2
Time to Cmax (Tmax) of Digoxin and Rosuvastatin
时间窗: Day 1 of Period 1 and Day 5 of Period 2
次要结局
- Percentage of Participants with Adverse Events (AEs)(From Day 1 until end of study participation (approximately 2 months))