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

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00681525
Collaborator
(none)
18
Enrollment
1
Location
3
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Jun 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. PK interaction [Study duration approximately 62 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 8087 Gainesville Florida United States 32608

    Sponsors and Collaborators

    • Abbott

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00681525
    Other Study ID Numbers:
    • M10-367
    First Posted:
    May 21, 2008
    Last Update Posted:
    Oct 19, 2010
    Last Verified:
    Sep 1, 2010
    Additional relevant MeSH terms:
    Atorvastatin
    Ezetimibe
    Fenofibric acid

    Study Results

    No Results Posted as of Oct 19, 2010