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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Rosuvastatin

Organic Anion Transporting Polypeptide1B1 (OATP1B1)

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01218347

SNUCPT10_Rosuvastatin_OATP1B1

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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