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

Rosuvastatin Clinical Trial

— OATP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218347
• Other study ID #: SNUCPT10_Rosuvastatin_OATP1B1
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2010
• Last updated: January 4, 2011
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Organic Anion Transporting Polypeptide1B1 (OATP1B1)
• Rosuvastatin

Intervention

Drug:
• Rosuvastatin
20 mg once daily for 21 days

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin		Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h	No
Secondary	lipid panel(LDL,HDL,TG,Total cholesterol)		Day 1 0h, Day 22 0h	No
Secondary	lipid metabolites		Day -1 0h, Day21 0h, 4h, 8h	No