NCT00808678

Brief Summary

The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1 healthy

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

Study Start

First participant enrolled

December 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

September 28, 2012

Status Verified

September 1, 2012

Enrollment Period

1 month

First QC Date

December 2, 2008

Last Update Submit

September 27, 2012

Conditions

Healthy

Keywords

Adverse Events

Outcome Measures

Primary Outcomes (2)

  • To determine the safety and tolerability of ABT-143 vs (ABT-335 + rosuvastatin) in healthy adults

    7 days

  • To determine the pharmacokinetic profile(s) for ABt-143 vs. (ABT-335 + rosuvastatin) in healthy adults

    7 days

Study Arms (2)

1

EXPERIMENTAL

ABT-143 capsules 20/135 mg

Drug: ABT-143

2

ACTIVE COMPARATOR

ABT-335 135 mg and rosuvastatin 20 mg

Drug: ABT-335Drug: rosuvastatin

Interventions

ABT-143DRUG

once, see arm description for more information

1
ABT-335DRUG

once, see arm description for more information

2
rosuvastatinDRUG

once, see arm description for more detail

2

Eligibility Criteria

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

You may qualify if:

  • A condition of general good health
  • BMI 19 to 29

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 14762

Orlando, Florida, 32809, 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, MD

    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

December 2, 2008

First Posted

December 16, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2009

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)