EUCTR2014-001197-34-GB进行中（未招募）1 期
A repeat-dose, open-label, parallel-group study to assess the pharmacokinetics of GSK1278863 and metabolites in subjects with End Stage Renal Disease undergoing peritoneal dialysis. - GSK1278863
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Satisfactory medical evaluation based upon medical history, medication history, physical examination, and clinical laboratory data obtained at the Screening visit. The determination of clinical significance will be made by the Investigator and the GSK Medical Monitor and will require that the finding is unlikely to introduce
- •additional risk factors or interfere with the study procedures, or the integrity of the study.
- •2. QTc < 470 msec OR QTc < 480 msec in subjects with Bundle Branch Block. These should be based on average of triplicate values obtained over a brief recording period at Screening and on Day -1 and the single reading on Day 17. The same QT correction formula should be used to determine inclusion and discontinuation for any individual subject throughout the study.
- •3. Vitamin B12 and folate above the lower limit of normal at Screening.
- •4. AST, ALT, and bilirubin = 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •5. A subject is eligible to enroll and participate in this study if he/she has ESRD and is on peritoneal dialysis for at least 2 months with estimated minimal residual kidney function (average urine output < 100 mL/daily) with stable Kt/V urea > 1.7 weekly.
- •6. No history of peritoneal dialysis-associated peritonitis, peritoneal catheter tunnel (exit site) infection or leakage for at least 3 months before study.
- •7. Meets the following erythropoiesis stimulating agent (ESA) criteria:
- •- Is ESA naive (i.e., no ESA use within the previous 12 weeks of screening)
- •- Agrees to discontinue ESA (if currently using ESA) for at least 7 days prior to first dose of GSK1278863 until completion of Follow-up visit.
- •a. If the subject has a scheduled ESA interval which is = 7 days, ESA
- •treatment must be discontinued for at least 7 days prior to first dose of
- •b. If the subject has a scheduled ESA interval which is > 7 days, ESA
- •treatment must be discontinued for at least the scheduled interval
- •length (e.g., if ESA interval is 14 days, then ESA must be discontinued
- •for > 14 days) prior to the first dose of GSK1278863
- •8. Has a hemoglobin value:
- •- For ESA naïve subjects: <10.0 g/dL
- •- For subjects receiving ongoing ESA treatment: Smaller than or equal to 11.0 g/dL at Screening.
- •9. Subjects who are = 18 years of age at the time of Screening.
- •10. A female subject is eligible to participate if she is of:
- •- Childbearing potential, and agrees to use one of the contraception methods described in the protocol. This criterion must be followed from the time of Screening until completion of the Follow-up Visit.
- •- Non-childbearing potential, defined as pre-menopausal females with a
排除标准
- •1. A positive test for HIV antibody.
- •2. Uncontrolled hypertension (diastolic BP >100 mmHg or
- •systolic BP >170 mmHg) at Screening.
- •3. History of drug abuse or dependence within 6 months of the study.
- •4. History of sensitivity to GSK1278863, or its components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- •5. History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical research unit uses heparin to maintain intravenous cannula patency).
- •6. History of thrombosis defined as deep vein thrombosis, stroke, pulmonary embolism or other thrombosis related condition within 3 months prior to Screening.
- •7. History of myocardial infarction or acute coronary syndrome within 3 months prior to Screening.
- •8. History of stroke or transient ischaemic attack within 3 months prior to Screening.
- •9. Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function that could interfere with the absorption, metabolism, and/or excretion of GSK1278863. Examples of conditions that could interfere with normal gastrointestinal anatomy or motility include gastrointestinal
- •bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy, malabsorption, Crohn’s disease, ulcerative colitis, or celiac sprue. Examples of conditions that could interfere with hepatic function include Gilbert’s syndrome.
- •10. Evidence of active peptic, duodenal or esophageal ulcer disease at Screening OR history of clinically significant GI bleeding within 3 months prior to Screening.
- •11. Subjects with chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease).
- •12. Subjects with a history of symptomatic right heart failure.
- •13. Subjects with Class III or Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
- •14. Active malignancy or diagnosis of malignancy within 5 years prior to Screening (excluding successfully treated basal or squamous cell carcinoma).
- •15. History of proliferative vascular eye disease (e.g., choroidal or retinal disease, such as neovascular age-related macular degeneration, proliferative diabetic retinopathy or macular edema) based upon having had an ophthalmologic exam within 12 months prior to Screening.
- •16. Pregnant females as determined by positive serum -hCG test at Screening or Day -1.
- •17. Lactating females.
- •18. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period prior to first dose.
- •19. Consumption of red wine, grapefruit (juice), blood orange (juice), star fruit, onions, kale, broccoli, green beans, or apples from 7 days prior to the first dose of investigational product until the Follow-up visit, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures and compromise subject safety.
- •20. Use or planned use
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