NCT00728780

Brief Summary

The purpose of this study is to compare the pharmacokinetics of ABT-335 and rosuvastatin from ABT-143 relative to that from the co-administration of ABT-335 and rosuvastatin.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

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

August 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

August 1, 2008

Last Update Submit

September 27, 2012

Conditions

Adverse EventsPharmacokinetic Variables

Keywords

Adverse eventsPharmacokinetic variables

Outcome Measures

Primary Outcomes (2)

  • Adverse events and safety laboratory assessments

    7 days

  • Pharmacokinetic parameters

    7 days

Study Arms (2)

A

EXPERIMENTAL

ABT-143 15/135mg

Drug: ABT-143

B

ACTIVE COMPARATOR

ABT-335 135mg and rosuvastatin 15mg

Drug: ABT-335 and rosuvastatin

Interventions

ABT-143DRUG

once

A
ABT-335 and rosuvastatinDRUG

once

B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Condition of good health

You may not qualify if:

  • Currently enrolled in another study
  • Females who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 11101

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Torbjörn Lundström

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

August 1, 2008

Primary Completion

September 1, 2008

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)