Back to resultsInfluence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring OATP1B1, Rosuvastatin, lipidomics, pharmacodynamics
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.
Sites / Locations
- Clinical Trials Center, Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rosuvastatin
Arm Description
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
Outcomes
Primary Outcome Measures
Changes of serum lipid levels from baseline for 8 weeks
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
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.
Full Information
NCT ID
NCT01466608
First Posted
October 27, 2011
Last Updated
May 15, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01466608
Brief Title
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
Official Title
Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
OATP1B1, Rosuvastatin, lipidomics, pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor Tablet 20 mg manufactured by Astrazeneca
Intervention Description
Oral administration of rosuvastatin 20 mg once daily for 21 days.
Primary Outcome Measure Information:
Title
Changes of serum lipid levels from baseline for 8 weeks
Description
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
Time Frame
Day 1, Day 15, Day 29, Day 43, Day 57
Secondary Outcome Measure Information:
Title
Urinary and plasma levels of the lipid metabolites for 8 weeks
Description
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.
Time Frame
Day 1, Day 15, Day 29, Day 43, Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Center, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Influence of OATP1B1 and BRCP Genotype on Rosuvastatin PK, PD and Lipidomics in Hyperlipidemic Patients
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