Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia|
- Changes of serum lipid levels from baseline for 8 weeks [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57 ] [ Designated as safety issue: No ]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
- Urinary and plasma levels of the lipid metabolites for 8 weeks [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57 ] [ Designated as safety issue: No ]The levels of the lipid metabolites in the samples collected prior to daily rosuvastatin dose on Day 1, Day 15, Day 29, Day 43, Day57 using UPLS-TOF-MS.
|Study Start Date:||November 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
Oral administration of rosuvastatin 20 mg once daily for 21 days.
Other Name: Crestor Tablet 20 mg manufactured by Astrazeneca
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466608
|Korea, Republic of|
|Clinical Trials Center, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-799|
|Principal Investigator:||Young Min Cho, MD, PhD||Seoul National University Hospital|