A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - Cmax (sitravatinib)
研究概览
简要总结
A Phase 1 Study of the Effect of Acid-reducing Agents on the Pharmacokinetics of a Single Oral Dose of Sitravatinib in Healthy Adult Subjects. The study is a single-center, open-label, 2-period, 2-treatment, fixed-sequence crossover, parallel-group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations at screening and/or check-in, as assessed by the investigator (or qualified designee).
- •Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at screening and check-in. Females of childbearing potential must agree to use contraception.
- •Male subjects must agree to use contraception.
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Significant history of 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 significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator.
- •History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. (Uncomplicated appendectomy and hernia repair are allowed. Cholecystectomy is not allowed.)
- •History of Gilbert's syndrome or suspicion of Gilbert's syndrome based on elevated total and indirect bilirubin (may be confirmed by repeat).
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to study drug administration on Day 1 of Period 1.
研究组 & 干预措施
Group 1 Treatment A (sitravatinib only)
Period 1: A single oral dose of 100 mg sitravatinib on Day 1
干预措施: Sitravatinib (Drug)
Group 1 Treatment B (sitravatinib and pantoprazole)
Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7
干预措施: Sitravatinib (Drug)
Group 1 Treatment B (sitravatinib and pantoprazole)
Period 2: Oral pantoprazole once daily for 7 days (Days 1 to 7) and a single oral dose of 100 mg sitravatinib on Day 7
干预措施: Pantoprazole (Drug)
Group 2 Treatment C (sitravatinib only)
Period 1: A single oral dose of 100 mg sitravatinib on Day 1
干预措施: Sitravatinib (Drug)
Group 2 Treatment D (sitravatinib and famotidine)
Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1
干预措施: Sitravatinib (Drug)
Group 2 Treatment D (sitravatinib and famotidine)
Period 2: A single oral dose of 100 mg sitravatinib followed by a single oral dose of famotidine 40 mg approximately 2 hours after sitravatinib dose on Day 1
干预措施: Famotidine (Drug)
结局指标
主要结局
Pharmacokinetics - Cmax (sitravatinib)
时间窗: Up to Day 7 after dosing
Maximum observed plasma concentration
Pharmacokinetics - AUClast (sitravatinib)
时间窗: Up to 72 hours after dosing
Area under the curve from time zero to the last measured time point
Pharmacokinetics - AUC∞ (sitravatinib)
时间窗: Up to 72 hours after dosing
Area under the plasma concentration-time curve from time zero extrapolated to infinity
次要结局
- Adverse Events (AEs)(Up to 9 weeks from screening)