A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe

October 18, 2010 updated by: Abbott
The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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
    • Florida
      • Gainesville, Florida, United States, 32608
        • Site Reference ID/Investigator# 8087

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subjects

Exclusion Criteria:

  • Clinically significant diseases or disorders
  • Positive screens for drug and alcohol
  • Pregnant or breast-feeding females
  • Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
ABT-335 135 mg
Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
Experimental: B
Atorvastatin 80 mg and Ezetimibe 10 mg
Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Names:
  • atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days
Experimental: C
ABT-335 135 mg, Atorvastatin 80 mg and Ezetimibe 10 mg
Drug: ABT-335
One ABT-335 135 mg capsule QD for 10 days
Other Names:
  • fenofibric acid
Drug: Atorvastatin
One 80 mg tablet of atorvastatin QD for 10 days
Other Names:
  • atovastatin
Drug: Ezetimibe
One ezetimibe 10 mg tablet QD for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK interaction
Time Frame: Study duration approximately 62 days
Study duration approximately 62 days

Collaborators and Investigators

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

Sponsor

Abbott

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

April 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-367

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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