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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01218347
First received: October 4, 2010
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Organic Anion Transporting Polypeptide1B1 (OATP1B1)
Rosuvastatin
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin [ Time Frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lipid panel(LDL,HDL,TG,Total cholesterol) [ Time Frame: Day 1 0h, Day 22 0h ] [ Designated as safety issue: No ]
  • lipid metabolites [ Time Frame: Day -1 0h, Day21 0h, 4h, 8h ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
rosuvastatin treatment
Drug: Rosuvastatin
20 mg once daily for 21 days

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218347

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University College of Medicine and Hospital
  More Information

No publications provided

Responsible Party: Kyung-Sang Yu/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01218347     History of Changes
Other Study ID Numbers: SNUCPT10_Rosuvastatin_OATP1B1
Study First Received: October 4, 2010
Last Updated: January 4, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
OATP1B1
rosuvastatin

Additional relevant MeSH terms:
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014