NCT00585143

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

December 22, 2007

Last Update Submit

September 27, 2012

Conditions

Dyslipidemia, Renal Insufficiency

Keywords

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

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

    Days 1, 8, 9, and 10

Secondary Outcomes (1)

  • Safety and tolerability of the study drugs

    Study duration

Study Arms (1)

1

EXPERIMENTAL
Drug: ABT-335Drug: Rosuvastatin

Interventions

ABT-335DRUG

45 mg once daily for 10 consecutive days

1
RosuvastatinDRUG

10 mg once daily for 10 days

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site Reference ID/Investigator# 6610

Gainesville, Florida, 32608, United States

Location

Site Reference ID/Investigator# 6738

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 7723

Minneapolis, Minnesota, 55404, United States

Location

Site Reference ID/Investigator# 7319

Knoxville, Tennessee, 37920, United States

Location

Site Reference ID/Investigator# 6928

San Antonio, Texas, 78209, United States

Location

Site Reference ID/Investigator# 8280

Richmond, Virginia, 23298-0160, United States

Location

MeSH Terms

Conditions

DyslipidemiasRenal Insufficiency

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acidRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torbjörn Lundström, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 3, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(6)