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A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.

NCT00388596 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-10-13

No results posted yet for this study

Summary

The first purpose of this study is to determine if taking SB-751689 along with Rosuvastatin (CRESTOR) or Atorvastatin (LIPITOR) will change how Rosuvastatin or Atorvastatin are absorbed and eliminated from the body. Rosuvastatin and Atorvastatin are prescription medications used to treat patients with high cholesterol. Patients who would take SB-751689 for osteoporosis might also take Rosuvastatin or Atorvastatin for high cholesterol. In an earlier study, SB-751689 was shown to lower the blood levels of Rosuvastatin when the two drugs were taken at the same time. Lower blood levels of Rosuvastatin could mean that it would not be as effective in lowering cholesterol. In this study SB-751689 will be taken alone, Rosuvastatin will be taken alone, SB-751689 and Rosuvastatin will be taken together, and SB-751689 will be taken 12 hours before Rosuvastatin is taken. This study will help determine if the two drugs should be taken 12 hour apart to prevent lower Rosuvastatin blood levels. Atorvastatin will be taken alone and at the same time as SB-751689 to determine if Atorvastatin blood levels are lower when taken at the same time as SB-751689.

A second purpose of this study is to determine if taking another drug called Ketoconazole (Nizoral) along with SB-751689 will change how SB-751689 is absorbed and eliminated from the body. Ketoconazole is a prescription medication used to treat patients with fungal and yeast infections.

Conditions

Interventions

DRUG

SB-751689

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials, MBChB, FRCP · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388596 on ClinicalTrials.gov