NCT01218347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 6, 2011

Status Verified

January 1, 2011

Enrollment Period

2 months

First QC Date

October 4, 2010

Last Update Submit

January 4, 2011

Conditions

Organic Anion Transporting Polypeptide1B1 (OATP1B1)Rosuvastatin

Keywords

OATP1B1rosuvastatin

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters(Tmax,Cmax,AUC) of rosuvastatin

    Day 21 0h, 1h, 2h, 3h, 4h, 5h, 8h, 12h, 24h

Secondary Outcomes (2)

  • lipid panel(LDL,HDL,TG,Total cholesterol)

    Day 1 0h, Day 22 0h

  • lipid metabolites

    Day -1 0h, Day21 0h, 4h, 8h

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

rosuvastatin treatment

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

20 mg once daily for 21 days

Rosuvastatin

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 11, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 6, 2011

Record last verified: 2011-01

Locations

KR(1)