A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
详细描述
This is a 2-part study with each part is an open-label study in healthy adult subjects.
Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;
- •Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;
- •Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.
排除标准
- •In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;
- •Allergic constitution (multiple drug and food allergies);
- •A history of alcoholism;
- •Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;
- •Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;
- •P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;
- •Female subjects are lactating or have positive blood pregnancy results during the screening period;
研究组 & 干预措施
Part A
Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: GLS4 (Drug)
Part A
Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: RTV (Drug)
Part A
Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: TAF (Drug)
Part B
Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: GLS4 (Drug)
Part B
Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: RTV (Drug)
Part B
Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
干预措施: TAF (Drug)
结局指标
主要结局
Adverse event
时间窗: Baseline to day 22
To assess the safety and tolerability of therapy.
Cmax
时间窗: predose to 96 hour after dosing
maximum observed plasma concentration
AUC
时间窗: predose to 96 hour after dosing
area under the plasma concentration-time curve (AUC)
次要结局
未报告次要终点