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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01466608
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : May 16, 2014
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rosuvastatin
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
Drug: Rosuvastatin
Oral administration of rosuvastatin 20 mg once daily for 21 days.
Other Name: Crestor Tablet 20 mg manufactured by Astrazeneca

Primary Outcome Measures :
  1. Changes of serum lipid levels from baseline for 8 weeks [ Time Frame: 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

Secondary Outcome Measures :
  1. Urinary and plasma levels of the lipid metabolites for 8 weeks [ Time Frame: Day 1, Day 15, Day 29, Day 43, Day 57 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01466608

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Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
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Responsible Party: Young Min Cho, Assistant professor, Seoul National University Hospital Identifier: NCT01466608    
Other Study ID Numbers: SNUCPT11_Rosuvastatin_Pt
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014
Keywords provided by Young Min Cho, Seoul National University Hospital:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors