An Open Label, Non-Randomized, Two-Treatment, Single-Period, Single-Dose, Drug-Drug Interaction Study to Evaluate the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) 90 mg Film-Coated Tablets in Healthy Adult Subjects Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration of Dasatinib (Cmax)
研究概览
简要总结
In this open label, single-sequence study, subjects received one dose of XS004 Dasatinib Amorphous Solid Dispersion Film-Coated Tablet, 90 mg Test Formulation at the start of study on Day 1 and Day 6. Omeprazole 40 mg was administered on Day 2, 3, 4, 5 and 6. The study was conducted in two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Age: 18-60 years
- •Sex: Healthy adult males (sterile or using contraception) and females of non-childbearing potential
- •Clinical laboratory values should be within the laboratory's stated normal range. If not within this range, they must be without clinical significance, as determined by the Investigator
- •No clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by the Investigator
- •Any abnormalities/deviations from the acceptable range of medical history, laboratory values, ECG, and vital signs that might be considered clinically relevant by the study physician or Investigator will be evaluated as individual cases
- •Able to comply with study procedures, in the opinion of the Investigator(s)
- •Willing to give written consent, pregnancy outcome consent, and adhere to all the requirements of this protocol
排除标准
- •Any major illness in the last three months or any significant ongoing chronic medical illness
- •Does not agree to consume the provided meals
- •Participation in any clinical trial 30 days prior to dosing
- •Positive results for drugs of abuse or alcohol breath analysis prior to dosing
- •Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen, Hepatitis C Virus, or anti-HBc tests
- •Females currently breastfeeding, demonstrating a positive pregnancy screen, or using hormone replacement therapy within three months prior to dosing
研究组 & 干预措施
Dasatinib ASD alone
At the clinic, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 1 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.
干预措施: Dasatinib ASD (Drug)
Dasatinib ASD + Omeprazole
At the clinic, on Day 2 to Day 6, participants were administered a single oral dose of Omeprazole 40 mg × 1 Delayed Release Capsule once before meals in the evening with approximately 150 mL of room temperature water. No food was allowed two hours before and one hour after administration of Omeprazole.
In addition, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 6 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.
干预措施: Dasatinib ASD (Drug)
Dasatinib ASD + Omeprazole
At the clinic, on Day 2 to Day 6, participants were administered a single oral dose of Omeprazole 40 mg × 1 Delayed Release Capsule once before meals in the evening with approximately 150 mL of room temperature water. No food was allowed two hours before and one hour after administration of Omeprazole.
In addition, participants were administered a single oral dose of 90 mg Dasatinib (Amorphous Solid Dispersion Film-Coated Tablet) on Day 6 after an overnight fast of at least 9 hours. Dasatinib was given with approximately 240 mL of room temperature water. Fasting continued for at least 4 hours following drug administration, after which a standardized lunch was served.
干预措施: Omeprazole 40 MG (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration of Dasatinib (Cmax)
时间窗: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Pharmacokinetic parameters (Cmax) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Area Under the Plasma Concentration-Time Curve from Zero to 24h
时间窗: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Pharmacokinetic parameters (AUC 0-24) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
Area Under the Plasma Concentration-Time Curve from Zero Extrapolated to Infinity
时间窗: Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.
Pharmacokinetic parameters (AUC 0-INF) for plasma dasatinib on Day 1 (Dasatinib alone) and on Day 6 (Dasatinib + Omeprazole) calculated for each subject using drug concentration-time data by non-compartmental methods.
次要结局
- Time of Maximum Observed Plasma Concentration of Dasatinib (Tmax)(Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.)
- Elimination Rate Constant (Kel)(Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.)
- Terminal Half-Life (T1/2)(Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.)
- Area Under the Plasma Concentration-Time Curve (Percent Extrapolation)(Blood samples collected at 15 time points (including pre-dose) during the study period on Day 1 and Day 6.)