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

Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration

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.

Study Overview

• Status: Completed
• Conditions: Organic Anion Transporting Polypeptide1B1 (OATP1B1); Rosuvastatin
• Intervention / Treatment: Drug: Rosuvastatin

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Clinical trials center, Seoul national university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rosuvastatin; rosuvastatin treatment	Drug: Rosuvastatin; 20 mg once daily for 21 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyung-Sang Yu, MD, PhD, Seoul National University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): January 6, 2011
• Last Update Submitted That Met QC Criteria: January 4, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: rosuvastatin; OATP1B1
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: SNUCPT10_Rosuvastatin_OATP1B1