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

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ClinicalTrials.gov Identifier: NCT01218347
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : January 6, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Organic Anion Transporting Polypeptide1B1 (OATP1B1) Rosuvastatin Drug: Rosuvastatin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of OATP1B1 Genotype on the Pharmacokinetics,Lipid Lowering Effect, and Lipid Profiles After Rosuvastatin Administration
Study Start Date : October 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin [ Time Frame: Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h ]

Secondary Outcome Measures :
  1. lipid panel(LDL,HDL,TG,Total cholesterol) [ Time Frame: Day 1 0h, Day 22 0h ]
  2. lipid metabolites [ Time Frame: Day -1 0h, Day21 0h, 4h, 8h ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kyung-Sang Yu/Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01218347     History of Changes
Other Study ID Numbers: SNUCPT10_Rosuvastatin_OATP1B1
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Seoul National University Hospital:
OATP1B1
rosuvastatin

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