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Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00365339
Collaborator
(none)
40
Enrollment
1
Location
5
Arms
2
Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Jun 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Drug: Atazanavir+Ritonavir+Tenofovir
Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
Other Names:
  • Abilify

    		•
    Experimental: B

    Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
    Other Names:
  • Abilify

    		•
    Experimental: C

    Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
    Other Names:
  • Abilify

    		•
    Experimental: D

    Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
    Other Names:
  • Abilify

    		•
    Experimental: E

    Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
    Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
    Other Names:
  • Abilify

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM. []

    Secondary Outcome Measures

    1. Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Hamilton New Jersey United States

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00365339
    Other Study ID Numbers:
    • AI424-287
    First Posted:
    Aug 17, 2006
    Last Update Posted:
    Apr 8, 2011
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    HIV
    Protease Inhibitor
    Additional relevant MeSH terms:
    HIV Infections
    Ritonavir
    Atazanavir Sulfate
    Tenofovir
    Aripiprazole
    Famotidine

    Study Results

    No Results Posted as of Apr 8, 2011