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

December 22, 2007
September 27, 2012
January 2008
October 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00585143 on ClinicalTrials.gov Archive Site
Safety and tolerability of the study drugs [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly
Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dyslipidemia, Renal Insufficiency
  • 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
Experimental: 1
Interventions:
  • Drug: ABT-335
  • Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
October 2008
October 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585143
M10-070
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Torbjörn Lundström, MD AstraZeneca
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP