Back to resultsA Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB-751689
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring SB-751689, osteoporosis, drug interaction, ketoconazole, atorvastatin, rosuvastatin
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
AUC and Cmax of SB-751689, rosuvastatin, and atorvastatin in blood or plasma.
Secondary Outcome Measures
AUC and Cmax of 2 metabolites of atorvastatin and PTH in plasma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00388596
Brief Title
A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
SB-751689, osteoporosis, drug interaction, ketoconazole, atorvastatin, rosuvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB-751689
Primary Outcome Measure Information:
Title
AUC and Cmax of SB-751689, rosuvastatin, and atorvastatin in blood or plasma.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
AUC and Cmax of 2 metabolites of atorvastatin and PTH in plasma.
Time Frame
throughout the study
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MBChB, FRCP
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
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