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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00585143
• Collaborator: (none)
• Enrollment: 37
• Locations: 6
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia, Renal Insufficiency	Drug: ABT-335; Drug: Rosuvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics of ABT-335 and Rosuvastatin in Subjects With Normal Renal Function and Renal Impairment
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ABT-335; 45 mg once daily for 10 consecutive days; Drug: Rosuvastatin; 10 mg once daily for 10 days

Outcome Measures

Primary Outcome Measures

1. Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin [Days 1, 8, 9, and 10]

Secondary Outcome Measures

1. Safety and tolerability of the study drugs [Study duration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 6610	Gainesville	Florida	United States	32608
2	Site Reference ID/Investigator# 6738	Miami	Florida	United States	33136
3	Site Reference ID/Investigator# 7723	Minneapolis	Minnesota	United States	55404
4	Site Reference ID/Investigator# 7319	Knoxville	Tennessee	United States	37920
5	Site Reference ID/Investigator# 6928	San Antonio	Texas	United States	78209
6	Site Reference ID/Investigator# 8280	Richmond	Virginia	United States	23298-0160

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Torbjörn Lundström, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00585143
• Other Study ID Numbers: M10-070
• First Posted: Jan 3, 2008
• Last Update Posted: Sep 28, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by AstraZeneca: Dyslipidemia
• Additional relevant MeSH terms: Renal Insufficiency; Dyslipidemias; Rosuvastatin Calcium

Study Results

No Results Posted as of Sep 28, 2012