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

Primary Purpose

Dyslipidemia, Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABT-335

Rosuvastatin

About this trial

This is an interventional treatment trial for Dyslipidemia, Renal Insufficiency focused on measuring Dyslipidemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Site Reference ID/Investigator# 6610
Site Reference ID/Investigator# 6738
Site Reference ID/Investigator# 7723
Site Reference ID/Investigator# 7319
Site Reference ID/Investigator# 6928
Site Reference ID/Investigator# 8280

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin

Secondary Outcome Measures

Safety and tolerability of the study drugs

Full Information

NCT ID

NCT00585143

First Posted

December 22, 2007

Last Updated

September 27, 2012

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00585143

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia, Renal Insufficiency

Keywords

Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ABT-335

Intervention Description

45 mg once daily for 10 consecutive days

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

10 mg once daily for 10 days

Primary Outcome Measure Information:

Title

Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin

Time Frame

Days 1, 8, 9, and 10

Secondary Outcome Measure Information:

Title

Safety and tolerability of the study drugs

Time Frame

Study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Torbjörn Lundström, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 6610

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Site Reference ID/Investigator# 6738

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Site Reference ID/Investigator# 7723

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55404

Country

United States

Facility Name

Site Reference ID/Investigator# 7319

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Site Reference ID/Investigator# 6928

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Site Reference ID/Investigator# 8280

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298-0160

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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