Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.