NCT00719693

Brief Summary

Single-dose, open-label, two-period crossover study of ABT-143

Trial Health

80
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at 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

Study Start

First participant enrolled

July 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
1 month 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

2 months

First QC Date

July 18, 2008

Last Update Submit

September 27, 2012

Conditions

Pharmacokinetic Variables

Keywords

Food effect, phase Iadverse events

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    7 days

Secondary Outcomes (1)

  • Adverse Events

    30 days

Study Arms (2)

A

EXPERIMENTAL

ABT-143 under low-fat meal condition

Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )

B

EXPERIMENTAL

ABT-143 under fasting meal condition

Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )

Interventions

ABT-143 (rosuvastatin calcium and fenofibric acid )DRUG

one dose under fasting meal condition

B

Eligibility Criteria

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

You may qualify if:

  • years of age (inclusive)
  • BMI 19 to 29 inclusive

You may not qualify if:

  • Asian ancestry
  • Concurrent participation in another study
  • Females pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site Reference ID/Investigator# 9242

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calciumfenofibric acid

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
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 22, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Last Updated

September 28, 2012

Record last verified: 2012-09

Locations

US(1)