ACTRN12623001038684已完成1 期
A Phase 1, Open-Label Trial to Evaluate the Potential Drug-Drug Interactions of AR882 with CYP2C9 Inhibitor, Inducer, and Substrate, and BCRP Substrate in Healthy Adult Participants
Arthrosi Therapeutics Australia Pty, Ltd a subsidiary of Arthrosi Therapeutics, Inc0 个研究点目标入组 54 人开始时间: 2023年9月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •* Male and/or childbearing or non-childbearing potential female participants
- •* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECG at the time of Screening, as deemed by the Investigator
- •* Body weight no less than 50 kg and body mass index (BMI) between 18 and 33 kg/m2
- •* Screening serum uric acid level greater than or equal to 4.5 mg/dL (268 µmol/L) and estimated glomerular filtration fate (eGFR, by Cockcroft Gault formula) greater than or equal to 90 mL/min.
排除标准
- •* Inadequate venous access or unsuitable veins for repeated venipuncture.
- •* Positive serology to HIV and/or hepatitis C virus , and/or hepatitis B surface antigen (HBsAg).
- •* History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders that are not well controlled as per the Investigator’s judgment.
- •* History and/or presence of drug addiction or excessive use of alcohol within 12 months.
- •* Heavy caffeine drinker, > 5 servings (8-ounce/240 mL per serving) of caffeinated beverages (e.g., coffee, tea, cola, etc.) per day.
研究者
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