Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Changes of serum lipid levels from baseline for 8 weeks
研究概览
简要总结
The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia patients.
详细描述
Within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. Study drugs will be administered at about 9 A.M. in the morning of the first drug administration day, after blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomic and genetic analyses.
Subjects should take the investigational product by themselves every morning for 8 weeks. On the days of 2nd, 4th, 6 and 8th week, blood collection for evaluation of pharmacokinetics, lipid profiles, metabolomics and urine collection for metabolomics will be conducted by visiting the clinical trials center. On the days of 2nd, 4th and 6th week, the study drug will be taken after blood and urine collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35 to 55 years at the time of screening
- •Serum LDL cholesterol (LDL-C) level ≤130 mg/dL
- •Must be reliable and willing to make themselves available during the study period
- •Must be willing to give blood sample for genotyping
排除标准
- •A subject with present clinical manifestation or past medical history of hepatic, renal, respiratory, neurologic, hematologic, oncologic, psychiatric, cardiovascular or endocrine disease, except hyperlipidemia and mild hypertension (SBP < 160 mmg, DBP <100 mmHg).
- •Administration of lipid lowering agent within 2 weeks before the first study drug administration.
- •A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which could influence the absorption of the study drug.
- •A subject with a history of drug abuse, or a positive urine drug screening test
- •A subject who takes or should take any medication that can influence lipid lowering effects or metabolic profiles of the study drug during the study period. (Investigators judge the wash-out period of the previously used medication before the administration of the study drug.)
- •A subject who has participated in any other clinical trial within 3 months before the study drug administration.
- •A subject who is judged to be ineligible to participate in the study due to abnormal clinical laboratory results or other reasons by investigators.
研究组 & 干预措施
Rosuvastatin
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Changes of serum lipid levels from baseline for 8 weeks
时间窗: Day 1, Day 15, Day 29, Day 43, Day 57
Changes of serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglyceride levels at fasting from baseline to Day 1, Day 15, Day 29, Day 43, Day 57
次要结局
- Urinary and plasma levels of the lipid metabolites for 8 weeks(Day 1, Day 15, Day 29, Day 43, Day 57)
研究者
Young Min Cho
Assistant professor
Seoul National University Hospital