ISRCTN16486589进行中（未招募）1 期
A Phase I, open label, single dose, randomized, two-period crossover study to evaluate the relative bioavailability of single oral doses of two different formulations of divarasib (GDC-6036; 200-mg tablet and 400-mg tablet) in healthy subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genentech
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males or females of non-childbearing potential
- •2. Body mass index (BMI) ranges from 18.0 to 32.0 kilogram per meter square (kg/m^2)
- •3. In good health, determined by no clinically significant findings from medical history, physical examination, triplicate 12-lead electro cardiogram (ECGs), and vital signs
- •4. Negative test for selected drugs of abuse at Screening (does not include alcohol) and at Check-in (Day -1 of Period 1) (does include alcohol)
- •5. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative Human Immunodeficiency Virus (HIV) antibody screens
- •6. Able to comply with the study protocol, including an overnight (at least 8 hours) fast before dosing
排除标准
- •1. Significant history or clinical manifestation of any metabolic, allergic (to any drug compound, food, or other substance), dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI) (stomach or intestinal surgery or resection), neurological, or psychiatric disorder
- •2. History of significant hypersensitivity, significant intolerance, or significant allergy to any drug compound, food, or other substance, unless approved by the investigator
- •3. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, before Check-in (Period 1 Day -1)
- •4. Receipt of a coronavirus disease 2019 (COVID-19) vaccine in the past 28 days before Check-in (Period 1 Day -1)
- •5. Use of any prescription medications/products within 14 days prior to Check-in (Period 1 Day -1), unless deemed acceptable by the investigator
- •6. Serious infection requiring oral antibiotics within 4 weeks or intravenous (IV) antibiotics within 8 weeks of Screening
- •7. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy and hernia repair will be allowed
研究者
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