Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

This study has been completed.

Sponsors and Collaborators:	Abbott AstraZeneca
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00585143

Purpose

The purpose of this study is to assess blood levels of ABT-335 and rosuvastatin in patients with impaired kidney function when administered together, and to compare how the blood levels may change in those with moderately impaired kidney function when given together compared to when given by themselves.

Condition	Intervention	Phase
Dyslipidemia Renal Insufficiency	Drug: ABT-335 Drug: Rosuvastatin	Phase I

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Further study details as provided by Abbott:

Primary Outcome Measures:

blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin [ Time Frame: Days 1, 8, 9, and 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of the study drugs [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

Enrollment:	37
Study Start Date:	January 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-335 45 mg once daily for 10 consecutive days Drug: Rosuvastatin 10 mg once daily for 10 days

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Body Mass Index (BMI) 19 to 33, inclusive
Either normal kidney function, or mild or moderate kidney impairment

Exclusion Criteria:

Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management of renal disease.
History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585143

Locations

United States, Florida

Gainesville, Florida, United States, 32608

Miami, Florida, United States, 33136
United States, Minnesota

Minneapolis, Minnesota, United States, 55404
United States, Tennessee

Knoxville, Tennessee, United States, 37920
United States, Texas

San Antonio, Texas, United States
United States, Virginia

Richmond, Virginia, United States

Sponsors and Collaborators

Abbott

AstraZeneca

More Information

Responsible Party:	Abbott ( Dawn Carlson, MD, MPH )
Study ID Numbers:	M10-070
Study First Received:	December 22, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00585143
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Dyslipidemia
Renal insufficiency

Study placed in the following topic categories:

Renal Insufficiency
Rosuvastatin
Metabolic Diseases
Urologic Diseases

Kidney Diseases
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009