ISRCTN57815030进行中（未招募）1 期
A two-part, open-label, comparative, single-dose, randomized, five-treatment, three-way crossover sequential study to assess the relative bioavailability of entrectinib capsule compared to nasogastric and oral administration of suspension in healthy subjects
F. Hoffmann-La Roche0 个研究点目标入组 31 人开始时间: 2022年8月3日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
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. Female of non-childbearing potential or male, between 18 and 55 years of age, inclusive, at Screening
- •2. Within body mass index (BMI) range of 18.0 to 32.0 kg/m², inclusive, and weighing at least 50 kg at Screening
- •3. Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history, physical examination, vital signs and 12-lead ECG assessment, and clinical laboratory evaluation results
- •4. Negative hepatitis panel (hepatitis B surface antigen and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens
- •5. Females must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each Check-in (Day -1)
排除标准
- •1. Women of childbearing potential, women who are pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the final dose of entrectinib
- •2. Males who have a pregnant partner
- •3. A clinically significant medical history of gastrointestinal (GI) surgery (e.g., gastric bypass) or other GI disorder (e.g., malabsorption syndrome) that might affect absorption of medicines from the GI tract.
- •4. Clinically significant lactose intolerance
- •5. Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible provided they are stable
- •6. A clinically significant abnormal physical examination finding
- •7. Use of moderate or potent inhibitors or inducers of CYP3A4 enzyme or P-glycoprotein (P-gp) transporter within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1). Additionally, for subjects enrolled in Part 2, use of moderate or potent inhibitors or inducers of CYP2C19 within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1)
- •8. Use of gastric pH-modifying agents such as protein pump inhibitor (PPIs), H2 receptor antagonists, and antacids, within 28 days or 5 half-lives, whichever is longer, before Period 1 dosing (Day 1)
- •9. Administration of a Coronavirus Disease 2019 vaccine in the past 7 days prior to Period 1 dosing (Day 1)
- •10. Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 60 days or 5 half-lives (if known), whichever is longer, prior to Period 1 dosing (Day 1)
- •11. Known history of clinically significant hypersensitivity, or severe allergic reaction, to entrectinib or related compounds (Part 1 and Part 2) or lansoprazole or related compounds (Part 2 only)
- •12. Previous enrollment in this study. Subjects who have taken part in Part 1 are not permitted to take part in Part 2
研究者
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