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

NCT ID: NCT01466608

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-08-31

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 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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Oral administration of rosuvastatin 20 mg once daily for 21 days.

Interventions

Rosuvastatin

Oral administration of rosuvastatin 20 mg once daily for 21 days.

Intervention Type: DRUG

Other Intervention Names

Crestor Tablet 20 mg manufactured by Astrazeneca

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Min Cho

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young Min Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUCPT11_Rosuvastatin_Pt

Identifier Type: -

Identifier Source: org_study_id