Taste Properties of Atazanavir and Cobicistat

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults

Conditions
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HIV in Adults

Intervention / Treatment
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* Drug: Atazanavir
* Drug: Cobicistat
* Drug: Active Pharmaceutical Ingredient


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Atazanavir and Cobicistat<br>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<br> <br> Drug: Cobicistat<br> <br> Drug: Active Pharmaceutical Ingredient<br> <br> * Other names: (API);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |