ACTRN12616000642482已完成1 期
A Phase I, Open-Label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of a Single Oral Dose of RVX000222 in Subjects with Severe Renal Impairment.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
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 80 Years（—）
- 性别
- All
入选标准
- •1. Male or female between 18 and 80 years old, inclusive;
- •2. If female, have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, or meet at least one of the following criteria: post-surgical sterilization or two years postmenopausal.
- •3. If subject is female of childbearing potential, subject must be willing to practice an acceptable non-hormonal method of birth control from Day 1 through until at least 30 days post study drug administration (e.g., abstinence);
- •4. Provide written informed consent before participation in the study;
- •5. Stable renal function, in the opinion of the Investigator, for at least 3 months prior to Screen visit.
- •Cohort 1: Renal Impairment Subjects:
- •6. Previously diagnosed with ESRD and not on dialysis (eGFR <30 mL/min/1.73m2).
- •Cohort 2: Healthy Subjects:
- •7. Healthy volunteers matched for age (plus or minus 10 years), weight (plus or minus 20%), and gender with the subjects in Cohort 1 (renal impaired subjects);
- •8. eGFR greater than or equal to 60 mL/min/1.73m2).
排除标准
- •1. Currently undergoing renal dialysis;
- •2. Have donated blood or plasma, in excess of 500 mL. during the 30-day period before Day -1;
- •3. History of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin;
- •4. Evidence of cirrhosis from liver imaging or biopsy, history of hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure, or a Child-Pugh score of at least 5 points;
- •5. Have active cholecystitis or gallbladder symptoms within 60 days before Day -1 (subjects who have had a cholecystectomy are not excluded from this study);
- •6. Type 2 diabetes mellitus with unstable disease or changes in therapy (30) days prior to Day -1 (clinical trial unit admission) may be excluded, as determined by the investigator and/or medical monitor;
- •7. Have a screening 12-lead ECG considered clinically significant by the investigator;
- •8. Body Mass Index (BMI) >40 kg/m2;
- •9. Have positive test results for, or evidence of active infection with human immunodeficiency virus type 1 or 2, hepatitis A, B, or C;
- •10. Hormonal contraceptives are not allowed during study participation by study subjects from Visit 1/Screen until 48 hours post study drug administration. Subjects who take hormone replacement therapy must be willing to discontinue their hormonal therapy if it is medically appropriate;
- •11. Current or recent (within 12 months prior to Screen) use of systemic immunosuppressants, including but not limited to, corticosteroids (prednisone equivalent of >20 mg/day for >2 weeks), azathioprine, or cyclosporine;
- •12. Use of strong inhibitors or inducers of CYP3A4/5, OATP1B1, and OAT1/3 within 30 days of five half-lives, whichever is longer, prior to Day -1 (clinical research unit admission) and during the study (e.g. Boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazone, opinvir/rionavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinarir, telaprevir, telithromycin, voriconazole, rifampin, carbamazepine, phenytoin, or probenecid);
- •13. Use of diclofenac or clavulanic acid from 7 days prior to Day 1 (treatment day) and during the study;
- •14. Use of >1.0g acetaminophen from Day -1 (clinical research unit admission) to Day 1 (treatment day);
- •15. Have consumed grapefruit juice within 7 days before Day -1 to 48 hours post study drug administration;
- •16. Have any known allergy or intolerance to any compound in RVX000222 or any other closely related compound;
- •17. Are unwilling to abstain from alcoholic beverages, caffeine or xanthine-containing products, and use of nicotine products during the clinical research unit confinement period;
- •18. Have a positive result on drugs of abuse screen testing (Screen and Day -1). If a subject tests positive for a drug of abuse, and has a current prescription for the drug to treat a defined indication, the subject may be eligible for the participation;
- •19. Alanine transaminase (ALT) or Aspartate transaminase (AST) >2.0 x upper limit of normal (ULN) at Screen;
- •20. Total bilirubin >1.5 x upper limit of normal at Screen;
- •21. Have participated in a clinical study and received any investigational medication within the last 30 days or five half-lives, whichever is long, preceding Day -1;
- •22. In the opinion of the investigator, are not able or willing to comply with the protocol.
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