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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Atazanavir
* Drug: Cobicistat
* Drug: Atazanavir/Cobicistat Mini-tablet


Participation Criteria
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Eligibility Criteria
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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

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence Group 1<br> | Drug: Atazanavir<br>* Specified dose on specified days<br>* Other names: Reyataz;Drug: Cobicistat<br>* Specified dose on specified days<br>* Other names: Tybost;Drug: Atazanavir/Cobicistat Mini-tablet<br>* Specified dose on specified days<br>* Other names: Evotaz;|
| Experimental: Treatment Sequence Group 2<br> | Drug: Atazanavir<br>* Specified dose on specified days<br>* Other names: Reyataz;Drug: Cobicistat<br>* Specified dose on specified days<br>* Other names: Tybost;Drug: Atazanavir/Cobicistat Mini-tablet<br>* Specified dose on specified days<br>* Other names: Evotaz;|
| Experimental: Treatment Sequence Group 3<br> | Drug: Atazanavir<br>* Specified dose on specified days<br>* Other names: Reyataz;Drug: Cobicistat<br>* Specified dose on specified days<br>* Other names: Tybost;Drug: Atazanavir/Cobicistat Mini-tablet<br>* Specified dose on specified days<br>* Other names: Evotaz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 17 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) |  | Up to 17 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) |  | Up to 17 days | 
| Apparent terminal plasma half-life (T-HALF) |  | Up to 17 days | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-T]) |  | Up to 17 days | 
| Observed plasma concentration at 24 hours (C24) |  | Up to 17 days | 
| Number of participants with Adverse Events (AEs) |  | Up to 75 days | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to 75 days | 
| Number of participants with AEs leading to discontinuation |  | Up to 75 days | 
| Number of participants with AEs leading to death |  | Up to 75 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 17 days | 
| Number of participants with vital sign abnormalities |  | Up to 17 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 17 days | 
| Changes in Taste Evaluation Questionnaire | Palatability evaluated on a scale from 1 (weak) to 9 (strong) | Up to 17 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, Atazanavir, Cobicistat, Reyataz, Tybost, Evotaz