Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00388596 |
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 |
---|---|---|
Osteoporosis |
Drug: SB-751689 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
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 |
Enrollment: | 36 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CR9108985 |
Study First Received: | October 13, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00388596 |
Health Authority: | United States: Food and Drug Administration |
SB-751689 osteoporosis drug interaction |
ketoconazole atorvastatin rosuvastatin |
Rosuvastatin Musculoskeletal Diseases Clotrimazole Miconazole Tioconazole Osteoporosis |
Bone Diseases, Metabolic Healthy Ketoconazole Bone Diseases Atorvastatin |
Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Therapeutic Uses |
Antifungal Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |