Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Up to three prior chemotherapy regimens
- •Measurable or non-measurable disease
- •Available for treatment and follow-up
排除标准
- •Neuropathy
- •Uncontrolled cardiovascular disease
- •Refusal to participate in genetic analysis
研究组 & 干预措施
Ixabepilone + rifampin
干预措施: ixabepilone (Drug)
Ixabepilone + rifampin
干预措施: Rifampin (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Cmax was obtained directly from the concentration-time data.
Total Body Clearance (CLT)
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
CLT was obtained directly from the concentration-time data.
Volume of Distribution at Steady-state (Vss)
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
Vss was obtained directly from the concentration-time data.
Time to Reach Maximum Observed Concentration (T Max)
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
T max was obtained directly from the concentration-time data.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [INF])
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
AUC (INF) was obtained directly from the concentration-time data.
Time Taken for Plasma Concentration to Reduce by 50 Percent or Apparent Terminal Plasma Elimination Half-life (T Half)
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
T half was obtained directly from the concentration-time data.
Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T])
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
AUC (0-T) was obtained directly from the concentration-time data.
Urine 6B-Hydroxycortisol to Cortisol Ratio on Day -1
时间窗: Day -1 (0-8 hours and 8-24 hours), 24 hours before starting of ixabepilone administration.
The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.
Mean Residence Time Adjusted for Infusion Time (MRT [INF])
时间窗: Blood samples were collected on Day 1 (pre-dose, then 1h30, 3h, 3h15, 3h30, 4h, 6h and 8h), Day 2, Day 3, Day 4 and Day 8 during ixabepilone administration and repeated for Cycle 2 (Days 22-25 and 29) during ixabepilone and rifampin co-administration.
(MRT \[INF\]) was obtained directly from the concentration-time data.
Urine 6B-Hydroxycortisol to Cortisol Ratio on Day 22
时间窗: Day 22 (0-8 hours and 8-24 hours) during ixabepilone and rifampin co-administration.
The urine 6B-hydroxycortisol to cortisol ratio is a measure of hepatic CYP3A4/3A5 activity, which is a potential marker of the rate of clearance of ixabepilone. The urine 6B-hydroxycortisol to cortisol ratios were calculated on Day -1.
次要结局
- Number of Participants Who Died and Who Experienced Other Serious AEs (SAEs), Grade 3-4 AEs, Drug-related AEs and AEs Leading to Study Drug Discontinuation(From Day 1 to 30 days after the last dose of study drug.)
- Number of Participants With Grade 3-4 Hematology Abnormalities(Screening, Day 1, Day 8, Day 15, Day 22 and Day 29-36.)
- Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Alanine Aminotransferase, Aspartate Aminotransferase, Bilirubin, Albumin and Phosphorous(Screening, Days 1 and 22.)
- Number of Participants With Grade 3-4 Serum Chemistry Abnormalities in Calcium, Magnesium, Potassium, Sodium, Glucose and Uric Acid.(Screening, Days 2 and 22.)
- Number of Participants With Clinically Meaningful Vital Signs Measures(From screening to the off treatment visit.)
- Number of Participants With Abnormal Physical Examination Findings(From screening to the off treatment visit.)
- QT Interval Corrected for Heart Rate (QTcF)(Data collected at 0, 1.5, 3, 4, 6, 8 and 24 hours after start of infusion.)
- Number of Participants With Identified ECG Abnormalities(Data collected at screening, Day -1 and Day 1 (at 0, 1.5, 3, 4, 6, 8 and 24 hours) after start of infusion.)