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

October 9, 2008 updated by: GlaxoSmithKline

An Open-Label, Partially Randomized, Interaction Study to Evaluate the Effects of SB-751689 on the Pharmacokinetics of Rosuvastatin and Atorvastatin or the Effects of Ketoconazole on the Pharmacokinetics of SB-751689 in Healthy Postmenopausal Female Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33169
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy ambulatory postmenopausal woman defined as being amenorrheic for at least 2 years
  • Non-smoker
  • Weight >110 lbs (>50 kg)
  • Body mass index within the range 19 - 29.9 kg/m2
  • are capable of giving written informed consent

Exclusion Criteria:

  • Have any clinically relevant abnormality identified on the screening history and physical or laboratory examination, 12-lead surface electrocardiogram (ECG) and/or 24 hour Holter, including QTc > 450 msec
  • Test positive urine drug screen or alcohol
  • Test positive for HIV, hepatitis B virus or hepatitis C virus
  • Smoker or have a history of smoking or use of nicotine containing products within one year of the study or >10 pack-year history of smoking overall
  • have a history of regular alcohol consumption exceeding 7 units/week (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
  • have a history of drug abuse within 6 months of the study
  • have participated in a trial with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
  • use of prescription or non-prescription drugs (including calcium tablets, calcium containing antacids, aspirin or nonsteroidal anti-inflammatory drugs), vitamins, herbal and dietary supplements, within 14 days prior to the first dose of study medication.
  • have consumed of grapefruit containing products within 14 days prior to the first dose of study medication
  • have donated of blood in excess of 500 mL within 56 days prior to dosing
  • have evidence of kidney or liver disease
  • have a history of significant gastrointestinal disease or a gastrointestinal surgical procedures
  • are sensitive to any of the study medications or components thereof
  • have a history of cardiovascular disease
  • have medical conditions which might alter bone metabolism
  • have a serum parathyroid hormone (iPTH) test, or vitamin D levels outside the normal range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC and Cmax of SB-751689, rosuvastatin, and atorvastatin in blood or plasma.
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
AUC and Cmax of 2 metabolites of atorvastatin and PTH in plasma.
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, MBChB, FRCP, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

October 13, 2006

First Submitted That Met QC Criteria

October 13, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR9108985

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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