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A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04263350
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
8.7
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults
Actual Study Start Date :
Feb 26, 2020
Actual Primary Completion Date :
Nov 12, 2020
Actual Study Completion Date :
Nov 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A:Fixed- dose combination mini-tablet

Drug: Atazanavir/Cobicistat
Specified Dose on Specified Days
Other Names:
  • ATV/COBI

    		•
    Experimental: Treatment B: Separate products taken at the same time

    Drug: Reyataz Atazanavir
    Specified Dose on Specified Days
    Other Names:
  • REYATAZ (ATV)

    • Drug: Cobicistat
    Specified Dose on Specified Days
    Other Names:
  • COBI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of Atazanavir (ATV) [Up to Day 10]

    2. Cmax of Cobicistat (COBI) [Up to Day 10]

    3. Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV [Up to Day 10]

    4. AUC(INF) of COBI [Up to Day 10]

    Secondary Outcome Measures

    1. Incidence of Serious Adverse Events (SAEs) [Up to 70 days]

    2. Incidence of AEs leading to discontinuation [Up to 40 days]

    3. Incidence of deaths [Up to 40 days]

    4. Marked abnormalities in clinical laboratory test results [Up to 40 days]

    5. Incidence of marked abnormalities in vital sign measurements: Blood Pressure [Up to 40 days]

    6. Incidence of marked abnormalities in vital sign measurements: Heart Rate [Up to 40 days]

    7. Incidence of marked abnormalities in Electrocardiogram (ECG) recording [Up to 40 days]

    8. Incidence of Palatability questionnaire results [Up to 40 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

    Inclusion Criteria:

    • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.

    • Women and men must agree to follow specific methods of contraception, if applicable.

    Exclusion Criteria:

    • History of a clinically significant drug rash or Stevens-Johnson Syndrome

    • History of Gilbert's Syndrome

    • Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment

    • Any major surgery within 4 weeks of study treatment administration

    • Any gastrointestinal surgery that could impact upon the absorption of study treatment

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PPD Development, LP Austin Texas United States 78744

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04263350
    Other Study ID Numbers:
    • AI424-567
    First Posted:
    Feb 10, 2020
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Healthy Participants
    Additional relevant MeSH terms:
    Atazanavir Sulfate
    Cobicistat

    Study Results

    No Results Posted as of Nov 23, 2021