Influence of Organic Anion Transporting Polypeptide1B1(OATP1B1) Genotype on Rosuvastatin PK, PD and Lipid Profiles

Phase 4

Completed

• Conditions: Organic Anion Transporting Polypeptide1B1 (OATP1B1); Rosuvastatin
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01218347
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study aimed to explore the influence of organic anion transporting polypeptide1B1 (OATP1B1) genotype on pharmacokinetics, lipid lowering effect and lipid profiles after rosuvastatin administration.

Detailed Description

Open, one arm, single sequence study for healthy volunteers are investigated. Thirty four subjects may be enrolled.

Rosuvastatin are administered once a day for 21 days. Before and after rosuvastatin administration, PK, PD and lipid profiles are investigated.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
• Weight: Over 55 kg, within ±20% of ideal body weight
• Must be reliable and willing to make themselves available during the study period
• Must be willing to give blood sample for genotyping

Exclusion Criteria

• History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
• History of a significant surgical resection of gastrointestinal tract except appendectomy
• History or evidence of drug abuse
• Use any medication during the last 14 days period before first dosing
• Hypersensitivity to HMG-CoA reductase inhibitor
• Judged to be inappropriate for the study by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	rosuvastatin treatment

Primary Outcome Measures

Name	Time	Method
pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin	Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h

Secondary Outcome Measures

Name	Time	Method
lipid panel(LDL,HDL,TG,Total cholesterol)	Day 1 0h, Day 22 0h
lipid metabolites	Day -1 0h, Day21 0h, 4h, 8h

Trial Locations

Locations (1)

Clinical Trials Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of