Status:
COMPLETED
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
35-55 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01466608
Start Date
November 1 2011
End Date
August 1 2013
Last Update
May 16 2014
Active Locations (1)
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1
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea, 110-799