Assessment of the Effect of Food on ABT-143 Bioavailability

September 27, 2012 updated by: AstraZeneca
Single-dose, open-label, two-period crossover study of ABT-143

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Site Reference ID/Investigator# 9242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-55 years of age (inclusive)
  • BMI 19 to 29 inclusive

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ABT-143 under low-fat meal condition
Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )
one dose under low-fat meal condition
Other Names:
  • ABT-143
  • fenofibric acid/rosuvastatin calcium
Experimental: B
ABT-143 under fasting meal condition
Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )
one dose under fasting meal condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Torbjörn Lundström, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 22, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-442

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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