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A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05236738
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
1.1
Anticipated Duration (Months)
36.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions
Anticipated Study Start Date :
May 28, 2022
Anticipated Primary Completion Date :
Jul 2, 2022
Anticipated Study Completion Date :
Jul 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Sequence Group 1

Drug: Atazanavir
Specified dose on specified days
Other Names:
  • ATV
  • Reyataz

    • Drug: Cobicistat
    Specified dose on specified days
    Other Names:
  • COBI
  • Tybost

    • Drug: Atazanavir/Cobicistat Mini-tablet
    Specified dose on specified days
    Other Names:
  • Evotaz

    		•
    Experimental: Treatment Sequence Group 2

    Drug: Atazanavir
    Specified dose on specified days
    Other Names:
  • ATV
  • Reyataz

    • Drug: Cobicistat
    Specified dose on specified days
    Other Names:
  • COBI
  • Tybost

    • Drug: Atazanavir/Cobicistat Mini-tablet
    Specified dose on specified days
    Other Names:
  • Evotaz

    		•
    Experimental: Treatment Sequence Group 3

    Drug: Atazanavir
    Specified dose on specified days
    Other Names:
  • ATV
  • Reyataz

    • Drug: Cobicistat
    Specified dose on specified days
    Other Names:
  • COBI
  • Tybost

    • Drug: Atazanavir/Cobicistat Mini-tablet
    Specified dose on specified days
    Other Names:
  • Evotaz

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to 17 days]

    2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 17 days]

    Secondary Outcome Measures

    1. Time of maximum observed plasma concentration (Tmax) [Up to 17 days]

    2. Apparent terminal plasma half-life (T-HALF) [Up to 17 days]

    3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) [Up to 17 days]

    4. Observed plasma concentration at 24 hours (C24) [Up to 17 days]

    5. Number of participants with Adverse Events (AEs) [Up to 75 days]

    6. Number of participants with Serious Adverse Events (SAEs) [Up to 75 days]

    7. Number of participants with AEs leading to discontinuation [Up to 75 days]

    8. Number of participants with AEs leading to death [Up to 75 days]

    9. Number of participants with clinical laboratory abnormalities [Up to 17 days]

    10. Number of participants with vital sign abnormalities [Up to 17 days]

    11. Number of participants with electrocardiogram (ECG) abnormalities [Up to 17 days]

    12. Changes in Taste Evaluation Questionnaire [Up to 17 days]

      Palatability evaluated on a scale from 1 (weak) to 9 (strong)

    Eligibility Criteria

    Criteria

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

    • Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/[height(m)]^2

    Exclusion Criteria:

    • Significant acute or chronic medical illness

    • History of a clinically significant drug rash, Stevens-Johnson Syndrome or Gilbert's Syndrome

    • Inability to swallow oral medication

    • Major surgery within 4 weeks of study treatment administration

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Syneos Health Clinical Research Services, Llc Miami Florida United States 33136

    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:
    NCT05236738
    Other Study ID Numbers:
    • AI424-578
    First Posted:
    Feb 11, 2022
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    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
    Atazanavir
    Cobicistat
    Reyataz
    Tybost
    Evotaz
    Additional relevant MeSH terms:
    Malnutrition
    Atazanavir Sulfate
    Cobicistat

    Study Results

    No Results Posted as of Jun 6, 2022