A Phase 4, Single-center, Open-label, Parallel Study to Evaluate the Drug Interaction Between Albuvirtide (ABT) and Rifampin（RIF） in Healthy Adult Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd
研究概览
简要总结
This study is designed to estimate the drug interaction between RIF and ABT. This will be a single-center, open-label, parallel study in healthy adult subjects.
详细描述
The purpose of this study is to describe and compare RIF and ABT pharmacokinetics following administration of 320mg ABT and 600mg RIF.12 subjects will receive 320mg ABT on Days 1、2、3、8 (Treatment 1). And 12 subjects will receive 600mg RIF daily for 16 days from Day 1 to 16, and receive 320mg ABT on Days 7、8、9 and 14 (Treatment 2).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, age between 18 and 65 years；
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including physical examination, laboratory tests, Chest X-ray, abdominal B-ultrasound and ECG; No serious liver and kidney dysfunction, normal albumin value, and other indicators are in the normal range；
- •Subjects weighing ≥50 kg and their BMI within the range 18.5-27.0 kg/m^2 (inclusive)；
- •Agrees not to consume alcohol during the study；
- •Both male and female subjects and their partners of childbearing potential agree to use contraception during the study；
- •Females of childbearing potential must have a negative serum pregnancy test at Screening visit prior to receiving the first dose of study drug；
- •ALT、AST、ALP and TBIL≤1×ULN；
- •Willing and able to participate in all aspects of the study, including use of intravenous medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
排除标准
- •A positive anti-HIV-1 antibody result；
- •A positive pre-study Hepatitis B surface antigen result；
- •A Positive Hepatitis C antibody result；
- •Syphilis infection as manifest by positive RPR；
- •History of tuberculosis (TB) or lung disease；
- •Currently active severe chronic diseases, metabolic diseases (such as diabetes), cardiovascular diseases, neurological and psychiatric diseases；
- •Any known allergy or antibodies to the study drug or rifampicin；
- •Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study；
- •Active alcohol or drug abuse；
- •Participation in an experimental drug trial(s) within 30 days or 5 half-lives of the Screening Visit；
- •Currently active or chronic gastrointestinal dysfunction, or liver and kidney function disorders, would affect the absorption, metabolism, and/or excretion of the study drug. Subjects with a history of cholecystectomy, pepticulcer, inflammatory bowel disease or pancreatitis should be excluded；
- •Use other prescription or over-the-counter medications, including vitamins, herbal medicines, or dietary supplements, 7 days prior to dosing or 5 half-life, unless the investigator believes that the drug will not interfere with the study procedure or compromise the safety of the subject；
- •Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
研究组 & 干预措施
Group 1: ABT
Intravenous infusion of 320 mg ABT on Day 1, 2, 3, and 8.
干预措施: ABT (Drug)
Group 2: ABT+RIF
600mg Rifampicin once daily from Day 1 to 16. Intravenous infusion of 320 mg ABT on Day 7, 8, 9 and 14.
干预措施: ABT (Drug)
Group 2: ABT+RIF
600mg Rifampicin once daily from Day 1 to 16. Intravenous infusion of 320 mg ABT on Day 7, 8, 9 and 14.
干预措施: RIF (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of ABT following ABT 320mg administration with and without RIF 600mg qd
时间窗: Up to 17 days
Pharmacokinetic(PK) parameters
Peak Plasma Concentration (Cmax) of RIF 600mg qd administration with and without ABT 320mg
时间窗: Up to 17 days
PK parameters
Area under the plasma concentration versus time curve (AUC) of ABT following ABT 320mg administration with and without RIF 600mg qd
时间窗: Up to 17 days
PK parameters
Area under the plasma concentration versus time curve (AUC) of RIF 600mg qd administration with and without ABT 320mg
时间窗: Up to 17 days
PK parameters
次要结局
- Number of subjects with abnormal findings for laboratory parameters(Up to 17 days)
- Number of subjects with adverse events.(Up to 17 days)
- Number of subjects with severity of adverse events(Up to 17 days)
研究者
Hongzhou Lu
professor
Shanghai Public Health Clinical Center