Dyslipidemia, Renal Insufficiency
Conditions
Keywords
Dyslipidemia
Brief summary
Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly
Interventions
DRUGABT-335
45 mg once daily for 10 consecutive days
DRUGRosuvastatin
10 mg once daily for 10 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin | Days 1, 8, 9, and 10 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the study drugs | Study duration |
Countries
United States
Outcome results
None listed