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.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00585143
First received: December 22, 2007
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Dyslipidemia, Renal Insufficiency
Drug: ABT-335
Drug: Rosuvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ABT-335
45 mg once daily for 10 consecutive days
Other Name: ABT-335
Drug: Rosuvastatin
10 mg once daily for 10 days
Other Name: Rosuvastatin

  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
Site Reference ID/Investigator# 6610
Gainesville, Florida, United States, 32608
Site Reference ID/Investigator# 6738
Miami, Florida, United States, 33136
United States, Minnesota
Site Reference ID/Investigator# 7723
Minneapolis, Minnesota, United States, 55404
United States, Tennessee
Site Reference ID/Investigator# 7319
Knoxville, Tennessee, United States, 37920
United States, Texas
Site Reference ID/Investigator# 6928
San Antonio, Texas, United States, 78209
United States, Virginia
Site Reference ID/Investigator# 8280
Richmond, Virginia, United States, 23298-0160
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Torbjörn Lundström, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00585143     History of Changes
Other Study ID Numbers: M10-070
Study First Received: December 22, 2007
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Dyslipidemia

Additional relevant MeSH terms:
Renal Insufficiency
Dyslipidemias
Kidney Diseases
Urologic Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014