A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent
- •Healthy men or women based on history, physical examination, laboratory examination and ECG.
- •Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
- •Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin
- •All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
- •Others as specified in the detailed protocol
排除标准
- •Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
- •Has a history of drug or food allergy.
- •Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
- •Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
- •Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age.
- •Female partners have fertility and reliable contraceptive measures of men.
研究组 & 干预措施
PK Group (Danoprevir,Ritonavir)
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;
干预措施: Ritonavir (Drug)
PK Group (Danoprevir,Ritonavir)
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;
干预措施: Danoprevir (Drug)
Placebo Group
ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;
干预措施: Ritonavir (Drug)
Placebo Group
ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: 40 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state
时间窗: Up to 16 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)
时间窗: Up to 16 days
次要结局
未报告次要终点