Multiple-Dose Pharmacokinetics, Safety and Tolerability of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of ABT-450
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics and safety of multiple oral doses of ABT-450/ritonavir/ABT-267 and ABT-333 when co-administered under non-fasting conditions in healthy Chinese adult participants.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be Chinese (i.e., of Chinese ancestry).
- •If female, participant must be either postmenopausal for at least 2 years, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control with male partner(s): total abstinence from sexual intercourse as the preferred life style of the subject, periodic abstinence is not acceptable; vasectomized partner(s); hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; intrauterine device (IUD); or double-barrier method (condoms, contraceptive sponge, or diaphragm with spermicidal jellies or creams)
- •Hormonal contraceptives, including but not limited to oral, topical, injectable or implantable varieties, may not be used during the study.
- •If male, the participant must be surgically sterile or practicing at least 1 of the following methods of contraception, and refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug: partner(s) using an IUD; partner(s) using oral, injected, intravaginal, or implanted methods of hormonal contraceptives; participant and/or partner(s) using double-barrier method (condoms, contraceptive sponge, diaphragm with spermicidal jellies or creams, or vaginal ring); or total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable
- •Body Mass Index (BMI) is ≥ 18 to < 30 kg/m^
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and chest x-ray (CXR).
排除标准
- •Use of any medications (prescription and over-the-counter), vitamins and/or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
- •History of epilepsy, any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disease or disorder.
- •Clinically significant abnormal ECG: ECG with QT interval corrected for heart rate using Fridericia's correction formula (QTcF) > 450 msec in females and > 430 msec in males, or ECG with second or third degree atrioventricular block.
- •Previous exposure to more than a single dose of ABT-450/r/ABT-267, or ABT-333 within the past 12 weeks, or previous participation in this study.
- •Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ritonavir, ABT-267, or ABT-333.
研究组 & 干预措施
ABT-450/r/ABT-267 + ABT-333
ABT-450/r/ABT-267 will be administered once daily in the morning and ABT-333 will be administered in the morning and evening for 14 days.
干预措施: ABT-450/r/ABT-267 (Drug)
ABT-450/r/ABT-267 + ABT-333
ABT-450/r/ABT-267 will be administered once daily in the morning and ABT-333 will be administered in the morning and evening for 14 days.
干预措施: ABT-333 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of ABT-450
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Trough Concentration (Ctrough) of ABT-450
时间窗: Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose
Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.
Maximum Plasma Concentration (Cmax) of ABT-267
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Maximum Plasma Concentration (Cmax) of Ritonavir
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-450
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of Ritonavir
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24) Post-dose of ABT-267
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours (AUC12) Post-dose of ABT-333
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, and 12 hours after the morning dose on Study Days 1 and 14
Maximum Plasma Concentration (Cmax) of ABT-333
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Cmax is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
Time to Maximum Plasma Concentration (Tmax) of ABT-450
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Tmax is the time it takes for a drug to achieve Cmax.
Time to Maximum Plasma Concentration (Tmax) of ABT-267
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Tmax is the time it takes for a drug to achieve Cmax.
Time to Maximum Plasma Concentration (Tmax) of ABT-333
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Tmax is the time it takes for a drug to achieve Cmax.
Time to Maximum Plasma Concentration (Tmax) of Ritonavir
时间窗: Prior to the morning dose (0 hour) and 1, 2, 3, 4, 6, 9, 12, 15, 18, and 24 hours after the morning dose on Study Days 1 and 14; and 36, 48, and 72 hours after the morning dose on Study Day 14
Tmax is the time it takes for a drug to achieve Cmax.
Trough Concentration (Ctrough) of ABT-267
时间窗: Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose
Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.
Trough Concentration (Ctrough) of ABT-333
时间窗: Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose
Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.
Trough Concentration (Ctrough) of Ritonavir
时间窗: Prior to the morning dose on Study Days 7, 9, 11, 13 and 14; 24 hours after Day 14 dose
Ctrough is the lowest concentration of a drug in the blood after administration in a dosing interval.
Number of participants with adverse events
时间窗: Daily for approximately 20 days
次要结局
未报告次要终点