An Assessment of the Effect of Food and Antacid on BIIB021 Pharmacokinetics in Subjects With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.
研究概览
简要总结
This study is designed to assess the effect of food and antacid use on the pharmacokinetic properties of BIIB021.
详细描述
This study has 2 phases (the Food Phase and the Antacid Phase), each consisting of a 2-period, 2-sequence, 2-treatment crossover design. The Food Phase will assess the effect of a high fat meal on the pharmacokinetics of 100 mg BIIB021, and the Antacid Phase will assess the effect of an antacid (ranitidine) on the pharmacokinetics of 450 mg BIIB021 in the same subjects. Ranitidine 150 mg will be taken the evening before and the morning of the antacid dosing day.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histologically or cytologically confirmed solid tumors who have failed or are not candidates for standard therapies or for whom no approved therapy is available.
- •Eastern Cooperative Oncology Group (ECOG) performance status of greater or equal to
- •Medically able to tolerate a high fat meal and to fast as per protocol.
- •Expected survival time of at least 3 months in the opinion of the Investigator.
- •Ability to take ranitidine as per protocol.
- •Must be able to swallow and retain oral medication.
- •Lab values consistent with adequate renal, hepatic, and bone marrow functions.
- •Electrocardiogram (ECG) with QTc of ≤450 msec for men or ≤470 msec for women and no clinically significant findings.
排除标准
- •Pregnant (positive pregnancy test) or nursing women.
- •Previous treatment with an Hsp90 inhibitor.
- •Use of antacids within 7 days of Study Day
- •Prior antitumor therapies, including prior experimental agents or approved antitumor therapies within 28 days of the first dose of BIIB
- •Major surgery or radiation within 28 days of the first dose of BIIB
- •Uncontrolled, severe medical illness, which in the opinion of the Investigator and/or Sponsor could compromise protocol objectives.
- •History of gastrectomy or major surgery to small intestine.
- •History of exocrine pancreatic insufficiency.
- •Chronic diarrhea (excess of 2 to 3 stools/day above normal frequency).
- •Active bacterial or viral infection requiring concurrent treatment.
- •History of hepatitis B or C or human immunodeficiency virus.
- •History of central nervous system metastasis.
- •Any thrombotic event occurred <3 months prior to Day
- •Conditions that may predispose subjects to seizures: History of seizure, previous significant head trauma
- •Drug or alcohol abuse.
研究组 & 干预措施
BIIB021 and Food
The food phase will assess the effect of a high fat meal on the pharmacokinetics of BIIB021.
干预措施: BIIB021 and Food (Drug)
BIIB021 and Antacid
Antacid phase will assess the effect of an antacid on the pharmacokinetics of BIIB021.
干预措施: BIIB0121 and Antacid (Drug)
结局指标
主要结局
The primary objective of the study is to assess the pharmacokinetics of BIIB021 taken under fed conditions compared to BIIB021 taken under fasting conditions in subjects with advanced solid tumors.
时间窗: Cycle 1, Day 3
次要结局
- To evaluate the safety and tolerability of BIIB021(6 months)
- To evaluate the antitumor activity of BIIB021(6 months)
- To evaluate the effect of BIIB021 on pharmacodynamic biomarkers.(6 months)
- To assess the pharmacokinetics of BIIB021 taken with an antacid (ranitidine) compared to BIIB021 taken with no antacid, both under fasting conditions(Cycle 1, Day 8 and Day 10)