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

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 is currently recruiting participants.
Verified by Abbott, May 2008

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Primary Completion Date:	August 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

Contacts


Contact: Susan M Buttler, BS	847-936-6391	susan.buttler@abbott.com

Locations


United States, Florida
		Recruiting
	Gainesville, Florida, United States, 32608
		Recruiting
	Miami, Florida, United States, 33136

United States, Minnesota
		Recruiting
	Minneapolis, Minnesota, United States, 55404

United States, Tennessee
		Recruiting
	Knoxville, Tennessee, United States, 37920

United States, Texas
		Not yet recruiting
	San Antonio, Texas, United States

United States, Virginia
		Not yet recruiting
	Richmond, Virginia, United States

Sponsors and Collaborators

Abbott

AstraZeneca

More Information

Responsible Party:	Abbott ( Dawn Carlson, MD, MPH )
Study ID Numbers:	M10-070
First Received:	December 22, 2007
Last Updated:	May 20, 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 October 28, 2008