Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00585143
  4. Details
NCT00585143 Clinical Trial

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

Dyslipidemia, Renal Insufficiency Clinical Trial

Official title:
Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00585143
Other study ID # M10-070
Secondary ID
Status Completed
Phase Phase 1
First received December 22, 2007
Last updated September 27, 2012
Start date January 2008
Est. completion date October 2008

Study information
Verified date September 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-335
45 mg once daily for 10 consecutive days
• Rosuvastatin
10 mg once daily for 10 days

Locations
Country Name City State
United States Site Reference ID/Investigator# 6610 Gainesville Florida
United States Site Reference ID/Investigator# 7319 Knoxville Tennessee
United States Site Reference ID/Investigator# 6738 Miami Florida
United States Site Reference ID/Investigator# 7723 Minneapolis Minnesota
United States Site Reference ID/Investigator# 8280 Richmond Virginia
United States Site Reference ID/Investigator# 6928 San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin Days 1, 8, 9, and 10 Yes
Secondary Safety and tolerability of the study drugs Study duration Yes