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

Phase 1

Completed

• Conditions: Dyslipidemia, Renal Insufficiency
• Interventions: Drug: ABT-335; Drug: Rosuvastatin

• Registration Number: NCT00585143
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-22
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-27
• Last Update Posted: 2012-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-335	-
1	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin	Days 1, 8, 9, and 10

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of the study drugs	Study duration

Trial Locations

Locations (6)

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# 7319; 🇺🇸 Knoxville, Tennessee, United States

Site Reference ID/Investigator# 6610; 🇺🇸 Gainesville, Florida, United States

Site Reference ID/Investigator# 6928; 🇺🇸 San Antonio, Texas, United States