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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00585143
First received: December 22, 2007
Last updated: September 27, 2012
Last verified: September 2012
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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 May 19, 2013