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Taste Properties of Atazanavir and Cobicistat

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02307656
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
80.9
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults
Actual Study Start Date :
Dec 12, 2014
Actual Primary Completion Date :
Sep 9, 2021
Actual Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Atazanavir and Cobicistat

Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API) Stage 2:Taste Optimization using API (flavours and sweeteners) Stage 3:Prototypes of the API - containing clinical trial materials

Drug: Atazanavir

Drug: Cobicistat

Drug: Active Pharmaceutical Ingredient
Other Names:
  • (API)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria [Every 6 weeks from the time of subject enrollment up to 2 years]

    2. Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria [Every 6 weeks from the time of subject enrollment up to 2 years]

    3. Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria [Every 6 weeks from the time of subject enrollment up to 2 years]

    4. Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria [Every 6 weeks from the time of subject enrollment up to 2 years]

    5. Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria [Every 6 weeks from the time of subject enrollment up to 2 years]

    Other Outcome Measures

    1. Incident of adverse events will be tabulated and reviewed for potential significance and clinical important [Approximately up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    • Men and women, ages ≥18 years

    • Subjects who are qualified professional sensory panelists

    • Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment

    Exclusion Criteria:

    • Any acute or chronic condition that may alter taste or smell sensory perception

    • Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration

    • Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Senopsys Llc Woburn Massachusetts United States 01801

    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:
    NCT02307656
    Other Study ID Numbers:
    • AI424-517
    First Posted:
    Dec 4, 2014
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atazanavir Sulfate
    Cobicistat

    Study Results

    No Results Posted as of Jan 5, 2022