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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01466608
First received: October 27, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: November 2011
Study Completion Date: August 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466608

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Young Min Cho, Assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01466608     History of Changes
Other Study ID Numbers: SNUCPT11_Rosuvastatin_Pt
Study First Received: October 27, 2011
Last Updated: May 15, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
OATP1B1
Rosuvastatin
lipidomics
pharmacodynamics

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014