Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 13, 2006
Last updated: October 9, 2008
Last verified: October 2008

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.

Condition Intervention Phase
Drug: SB-751689
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • AUC and Cmax of SB-751689, rosuvastatin, and atorvastatin in blood or plasma. [ Time Frame: throughout the study ]

Secondary Outcome Measures:
  • AUC and Cmax of 2 metabolites of atorvastatin and PTH in plasma. [ Time Frame: throughout the study ]

Enrollment: 36
Study Start Date: October 2006

Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00388596

United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MBChB, FRCP GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00388596     History of Changes
Other Study ID Numbers: CR9108985
Study First Received: October 13, 2006
Last Updated: October 9, 2008

Keywords provided by GlaxoSmithKline:
drug interaction

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Rosuvastatin Calcium
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on April 26, 2017