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

Hypercholesterolemia Clinical Trial

Official title:

Lipid Lowering Effect, and Lipidomic Profiles by Genotype of OATP1B1 and BCRP After Administration of Rosuvastatin in Patients With Hyperlipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466608
• Other study ID #: SNUCPT11_Rosuvastatin_Pt
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: May 15, 2014
• Start date: November 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
Oral administration of rosuvastatin 20 mg once daily for 21 days.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1, Day 15, Day 29, Day 43, Day 57	No
Secondary	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.	Day 1, Day 15, Day 29, Day 43, Day 57	No