ISRCTN14383396进行中（未招募）1 期
A multiple-center, open-label, non-randomized study to investigate the effect of various degrees of hepatic impairment on the pharmacokinetics of a single intravenous dose of RO7223280
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入排标准
- 性别
- All
入选标准
- •1. Male and female participants aged 18 to 75 years of age, inclusive, at screening
- •2. Participants must have a body weight of at least 50 kg and a body mass index (BMI) within the range of 18 to 40 kg/m² (inclusive)
- •Additional inclusion criteria for participants with normal hepatic function:
- •3. Participants must be in reasonably good health as determined by the Investigator
- •4. Matched to participants with mild, moderate, or severe hepatic impairment in sex, age (± 10 years), and BMI (± 15%)
- •Additional inclusion criteria for participants with hepatic impairment only:
- •5. Documented chronic stable liver disease (Child-Pugh class A, B, or C, at screening); diagnosis of cirrhosis due to parenchymal liver disease. This will exclude biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder
- •6. Anemia secondary to hepatic disease will be acceptable, if hemoglobin =9 g/dL and anemia symptoms are not clinically significant as judged by the Investigator (or designee), Sponsor and Medical Monitor
- •7. Participants must have a platelet count =25,000/µL
排除标准
- •1. History or evidence of any medical conditions (e.g., gallbladder removal, malabsorption syndromes) potentially altering the absorption, distribution, metabolism, or elimination of drugs
- •2. History or presence of clinically significant electrocardiogram (ECG) abnormalities based on the average of the triplicate ECG recordings (e.g., PQ/PR interval >210 ms), QT corrected for heart rate using the Fridericia’s correction factor (QTcF) >480 ms or clinically significant cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease with recent myocardial infarction within the past 2 months, clinically significant cardiomyopathy, decompensated congestive heart failure, family history of congenital long QT syndrome, family history of sudden death)
- •3. History of unstable diabetes mellitus (as evidenced by hemoglobin A1c =9.0% [75 mmol/mol] at screening)
- •4. Vaccination is prohibited within 1 month prior to Day 1
- •5. Minimal smoking (up to 10 cigarettes/day) may be allowed at the discretion of the Investigator in discussion with the Sponsor and Medical Monitor. Participants will not be permitted to smoke within 2 hours prior to dose or 4 hours post-dose on Day 1
- •6. Evidence of human immunodeficiency virus (HIV) infection and/or positive result for human HIV antibodies.
- •7. Evidence of hepatorenal syndrome and estimated creatinine clearance range <60 ml/min or clinically significant abnormal sodium and potassium levels
- •8. Participants with insufficient venous access
- •9. History of hypersensitivity to any of the excipients in the formulation of RO7223280
- •Additional inclusion criteria for participants with normal hepatic function
- •10. Acute diseases or medical/surgical procedure with clinical significance (determined by the Investigator) within 2 weeks prior to screening, including gastrointestinal [GI] diseases and infections (such as respiratory or central nervous system infections)
- •11. Significant history or clinical manifestation of hepatic disorder
- •12. History or presence of liver disease or liver injury
- •13. Presence of hepatitis B surface antigen or positive hepatitis C antibody test result
- •Additional inclusion criteria for participants with hepatic impairment only:
- •14. Acute diseases or medical/surgical procedure with clinical significance (determined by the Investigator) within 2 weeks prior to screening, including GI diseases and infections (such as respiratory, central nervous system infections, or spontaneous bacterial peritonitis)
- •15. Current functioning organ transplant or are waiting for an organ transplant
- •16. Evidence of severe ascites
- •17. Presence of a portosystemic shunt, except for participants with severe hepatic impairment
- •18. Participants in current need for paracentesis within 1 month, prior to Day 1
- •19. History of GI hemorrhage due to esophageal varices or peptic ulcers less than 6 weeks prior to screening
- •20. History within 90 days prior to the screening visit or current symptoms of hepatic encephalopathy Grade 2 or above
- •21. Worsening of hepatic encephalopathy within 1 month prior to Day -1
- •22. Use of rifaximin for the treatment of
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the effects of various degrees of reduced kidney function on how the study drug (RO7223280) is broken down and eliminated from the bodyInfections and InfestationsBacterial infectionISRCTN39200026F. Hoffmann-La Roche70
招募中
4 期
Study to assess effectiveness of indacaterol in COPD patients in real life settingsCTRI/2013/09/004004ovartis Healthcare Private Limited4,500
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.EUCTR2013-002513-35-BEovartis Pharma Services AG3,183
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.Acute heart failureEUCTR2013-002513-35-ISovartis Pharma Services AG3,183
进行中（未招募）
1 期
Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.Acute heart failureEUCTR2013-002513-35-GBovartis Pharma Services AG2,650