Status:
COMPLETED
A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis
Eligibility:
FEMALE
Up to 65 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00388596
Start Date
October 1 2006
Last Update
October 13 2008
Active Locations (1)
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1
GSK Investigational Site
Miami, Florida, United States, 33169