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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01218347

Acronym

OATP

Enrollment

Registered

2010-10-11

Start date

2010-10-31

Completion date

2010-12-31

Last updated

2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organic Anion Transporting Polypeptide1B1 (OATP1B1), Rosuvastatin

Keywords

OATP1B1, rosuvastatin

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.

Interventions

DRUGRosuvastatin

20 mg once daily for 21 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026