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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Atazanavir/Cobicistat
* Drug: Reyataz Atazanavir
* Drug: Cobicistat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A:Fixed- dose combination mini-tablet<br> | Drug: Atazanavir/Cobicistat<br>* Specified Dose on Specified Days<br>* Other names: ATV/COBI;|
| Experimental: Treatment B: Separate products taken at the same time<br> | Drug: Reyataz Atazanavir<br>* Specified Dose on Specified Days<br>* Other names: REYATAZ (ATV);Drug: Cobicistat<br>* Specified Dose on Specified Days<br>* Other names: COBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of Atazanavir (ATV) |  | Up to Day 10 | 
| Cmax of Cobicistat (COBI) |  | Up to Day 10 | 
| Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV |  | Up to Day 10 | 
| AUC(INF) of COBI |  | Up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events (SAEs) |  | Up to 70 days | 
| Incidence of AEs leading to discontinuation |  | Up to 40 days | 
| Incidence of deaths |  | Up to 40 days | 
| Marked abnormalities in clinical laboratory test results |  | Up to 40 days | 
| Incidence of marked abnormalities in vital sign measurements: Blood Pressure |  | Up to 40 days | 
| Incidence of marked abnormalities in vital sign measurements: Heart Rate |  | Up to 40 days | 
| Incidence of marked abnormalities in Electrocardiogram (ECG) recording |  | Up to 40 days | 
| Incidence of Palatability questionnaire results |  | Up to 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants