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

Completed · Phase 1

Conditions studied: Dyslipidemia, Renal Insufficiency

In brief

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

Key facts

Study ID

NCT00585143

Run by

AstraZeneca

People needed

37

Starts

2008-01-01

Expected to finish

2008-10-01

Last updated by the study team

2012-09-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body Mass Index (BMI) 19 to 33, inclusive
• Either normal kidney function, or mild or moderate kidney impairment

You may not qualify if…

• 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.

Where it is running

• Site Reference ID/Investigator# 6610 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 6738 — Miami, Florida, United States
• Site Reference ID/Investigator# 7723 — Minneapolis, Minnesota, United States
• Site Reference ID/Investigator# 7319 — Knoxville, Tennessee, United States
• Site Reference ID/Investigator# 6928 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 8280 — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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