An Open-Label, Sequential Design Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Maximum observed plasma concentration of PCI-32765
研究概览
简要总结
The purpose of this study is to assess the potential effects of rifampin on the pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy participants.
详细描述
This is an open-label (all people know the identity of the intervention), single center (study conducted at one site), sequential study (it is a design in a single group of participants are administered one or more study medication in a sequence) to evaluate the potential effects of rifampin on the pharmacokinetics of PCI-32765 in healthy participants.The study consists of 3 phases: screening phase (21 days prior to first dose of study medication), treatment phase (14 days), and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, a single dose of PCI-32765 560 mg will be administered orally on Day 1 and Day 11. Rifampin 600 mg (2 X 300 mg) will be administered orally on Days 4 to 13; followed by a single dose of PCI-32765 on Day 11. Follow up will be continued until Day 14. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The duration of the study will be approximately for 45 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
- •Agrees to protocol-defined use of effective contraception
排除标准
- •Participants with medically significant cardiac disease, hematologic, lipid abnormalities, significant pulmonary disease (bronchospastic respiratory), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease and infectious disease
- •Abnormal clinical laboratory and physical examination and vital signs
- •Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 3 days before the first dose of the study drug is scheduled
- •Positive to human immunodeficiency virus-type 1 (HIV-1) or HIV-2 test and hepatitis A, B or C infection at screening
研究组 & 干预措施
PCI-32765 + Rifampin
Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13.
干预措施: PCI-32765 (Drug)
PCI-32765 + Rifampin
Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13.
干预措施: Rifampin (Drug)
结局指标
主要结局
Maximum observed plasma concentration of PCI-32765
时间窗: Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of PCI-32765
时间窗: Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765
时间窗: Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
次要结局
- Obsreved plasma concentrations of metabolite PCI-45227(Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14)
- Number of participants with adverse events(up to 45 days)