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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00388596

Purpose

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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study 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:

MedlinePlus related topics: Cholesterol Drug Reactions Osteoporosis

Drug Information available for: Ketoconazole Fungarest Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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

Intervention Details:

Other Name: SB-751689

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388596

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MBChB, FRCP

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00388596 History of Changes
Other Study ID Numbers:	CR9108985
Study First Received:	October 13, 2006
Last Updated:	October 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

SB-751689
osteoporosis
drug interaction

ketoconazole
atorvastatin
rosuvastatin

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ketoconazole
Atorvastatin
Rosuvastatin
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012