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

NCT ID: NCT01218347

Last Updated: 2011-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Organic Anion Transporting Polypeptide1B1 (OATP1B1) Rosuvastatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

rosuvastatin treatment

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

20 mg once daily for 21 days

Interventions

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Rosuvastatin

20 mg once daily for 21 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Kyung-Sang Yu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine and Hospital

Locations

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Clinical Trials Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUCPT10_Rosuvastatin_OATP1B1

Identifier Type: -

Identifier Source: org_study_id

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