A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
- •Life expectancy of 12 weeks or greater.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
- •Able to swallow and retain oral medication.
- •Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
- •Non-childbearing potential.
排除标准
- •History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- •Evidence of refractory ascites.
- •Has clinically relevant or significant electrocardiogram abnormalities.
研究组 & 干预措施
Part 1, Bioequivalence Sequence Group 2
Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.
干预措施: Veliparib, capsule (Drug)
Part 1, Bioequivalence Sequence Group 1
Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.
干预措施: Veliparib, capsule (Drug)
Part 1, Bioequivalence Sequence Group 1
Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.
干预措施: Veliparib, tablet (Drug)
Part 2, Extension
Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
干预措施: Veliparib, capsule (Drug)
Part 2, Extension
Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
干预措施: Carboplatin (Drug)
Part 2, Extension
Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
干预措施: Paclitaxel (Drug)
Part 1, Bioequivalence Sequence Group 2
Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.
干预措施: Veliparib, tablet (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to approximately 8 days after initial dose of study drug
Maximum observed plasma concentration (Cmax)
Time to Maximum Observed Plasma Concentration (Tmax)
时间窗: Up to approximately 8 days after initial dose of study drug
Time to maximum observed plasma concentration (Tmax).
Apparent Terminal Phase Elimination Rate Constant (β or Beta)
时间窗: Up to approximately 8 days after initial dose of study drug
Apparent terminal phase elimination rate constant (β or Beta).
Terminal Phase Elimination Half-life (t1/2)
时间窗: Up to approximately 8 days after initial dose of study drug
Terminal phase elimination half-life (t1/2)
Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
时间窗: Up to approximately 8 days after initial dose of study drug
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
AUC from time 0 to infinite time (AUC∞)
时间窗: Up to approximately 8 days after initial dose of study drug
AUC from time 0 to infinite time (AUC∞)
次要结局
未报告次要终点